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EC number: 205-426-2 | CAS number: 140-66-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Two primary dermal irritation studies according to OECD 404 are available (Safepharm Laboratories Ltd. 1991 (Report 47/1579, GLP) and Hüls 1984 (Report 0225)). Additional data is provided as part of a poorly documented non-guideline study covering several endpoints (Rohm & Haas, 1973) and from a skin corrosivity evaluation study (Biodynamics IUnc., 1982). p-octylphenol is considered to be irritating to the skin.
Eye irritation was assessed in two acute eye irritation studies according to OECD 405 (Hüls AG, 1984 (Report 0226), Safepharm Laboratories Ltd. , 1991 (Report 47/1580) and as part of a poorly documented non-guideline study covering several endpoints (Rohm & Haas, 1973). p-octylphenol is considered to cause severe eye damage.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 18/01/1991-25/01/1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study (OECD 404)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: twelve to sixteen weeks old
- Weight at study initiation: 2.30-2.70 kg
- Housing: individually housed in suspended metal cages
- Diet: ad libitum (Spillers Rabbit Diet, Dalgety Agriculture Ltd., Almondsbury, Bristol)
- Water: ad libitum (drinking water)
- Acclimation period: minimum acclimatisation period of five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21°C
- Humidity (%): 45-56%
- Air changes (per hr): approximately 15 changes/hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test material, moistened with 0.5 ml of distilled water, was introduced under a 2.5 x 2.5 cm gauze patch and placed in position on the clipped skin;
- after 4 h application the corset and patches were removed and residual test material removed by gently swabbing with cotton wool soaked in distilled water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours. Additional observation on day 7 to assess the reversibility of skin reactions
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 0.5 g of the test material, moistened with 0.5 ml of distilled water, was introduced under a 2.5 x 2.5 cm gauze patch and placed in position on the shorn skin
- Type of wrap if used: The patch was secured in position with a strip of surgical adhesive tape (BLENDERM: approximate size 2.5 x 4.0 cm). To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP) and the animals were returned to their cages for the duration of the exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: four hours
SCORING SYSTEM: according to the scale from Draize J. H. (1959) Association of Food and Drug Officials of the United States, Austin, Texas, "The appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48, 72 hours & 7 days
- Score:
- 0 - 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48, 72 hours & t days
- Score:
- 0 - 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48, 72 hours & 7 days
- Score:
- 0 - 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48, 72 hours & 7 days
- Score:
- 0 - 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48, 72 & 7 days
- Score:
- 0 - 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48, 72 hours & 7 days
- Score:
- 0 - 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- other: (S/6) S = sum of 24 & 72 hours readings
- Score:
- 1.2
- Max. score:
- 8
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.7 - 1
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0 - 0.7
- Max. score:
- 4
- Irritant / corrosive response data:
- Very slight erythema was noted at all treated skin sites one, 24 and 48 hours after patch removal and at two treated skin sites at the 72 hour observation.
Slight oedema was noted at one treated skin site one hour after patch removal. Very slight oedema was noted at the two remaining treated skin sites at this time and at two treated skin sites at the 24 and 48 hour observations.
All treated skin sites appeared normal seven days after treatment. - Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The test material produced a primary irritation index of 1.2 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted. The test material was not classified as irritant to skin in rabbits.
- Executive summary:
In a primary dermal irritation study according to OECD 404, 3 New Zealand White rabbits were dermally exposed to 0.5 g of 4-(1,1,3,3-tetramethylbutyl)phenol (98.97% GC) in distilled water for 4 hours to 2.5 x 2.5 cm of body surface area. Residual substance was removed. Animals then were observed for 7 days. Irritation was scored according to Draize (1959).
Very slight erythema was noted at all treated skin sites one, 24 and 48 hours after patch removal and at two treated skin sites at the 72 hour observation. Slight oedema was noted at one treated skin site one hour after patch removal. Very slight oedema was noted at the two remaining treated skin sites at this time and at two treated skin sites at the 24 and 48 hour observations.
All treated skin sites appeared normal seven days after treatment.
4-(1,1,3,3-tetramethylbutyl)phenol is a mild dermal irritant based on a primary irritation index of 1.2.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November - December 19982
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Meets national standard methods with acceptable restrictions; test substance poorly described as "octylphenol"; no data on purity & impurities available
- Qualifier:
- according to guideline
- Guideline:
- other: DOT regulation 173.1300 (46 FR 49889)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Dutchland, Inc. Denver, Pennsilvania
- Age at study initiation: young adults
- Weight at study initiation: no data
- Housing: individually in suspended stainless stell steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 36 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 60-70°F
- Humidity (%): monitored daily
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- physiological saline
- Remarks:
- 0.5 ml of 0.9%
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Purity: 0.9% saline - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 48 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: back from to the scapular to the lumbar region
- Type of wrap if used: 1"x1" surgical gauze square, eight layers thick
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with castile soap and warm water and rinsed immediately after the 4 hour dermal evaluation
- Time after start of exposure: immediately
SCORING SYSTEM: Draize Method, Primary irritation index (modified from method presented in Federal Hazardous Substances Yct Regulations, 16 CFR 1500) - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 4 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: (superficial) necrosis
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 4 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- primary dermal irritation index (PDII)
- Score:
- 4.5
- Remarks on result:
- other: calculated as "Total Sum/ 2"
- Irritant / corrosive response data:
- Raw data will be retained on file in the Bio/dynamics Archives.
Dermal Scores - 4 and 48 Hours:
Time Interval Observation Animal No. And Sex (M=male, F=female) N=Necrosis
391M 392F 395M 398F 403M 405M
4 hours Erythema 2 2 2 2 2 2
Edema 1 1 2 2 2 2
48 hours Erythema 2 4Nb 4N 2 4Nb 4Nb
Edema 2 2 2 2 2 2
Nb = Superficial necrosis - Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Test material (referred to as octylphenol) is considered to be corrosive to the skin
- Executive summary:
In a primary dermal irritation study young adult New Zealand White rabbits (4 males, 2 females) were dermal exposed to 0.5 g of Octylphenol in saline for 4 hours to the back from the scapular to the lumber region. Animals then were observed for 2 days. Irritation was scored by the method of Draize. The primary irritation index is 4.5. Four of six animals exhibited evidence of tissue destruction (necrosis) at 48 hours.
In this study, Octylphenol is corrosive to the skin. The study is not considered to be reliable due to the poor characterization of the test substance.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Documentation insufficient for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Six New Zealand albino rabbits, 2 to 3 kg, were closely clipped over the back and sides with an Oster electric clipper. A 0.5 ml portion of the test material was introduced under a 1.5 inch, 12-ply gauze patch placed directly over the test site and held in place with Dermicel tape. The rabbits were wrapped with rubber damming for an exposure period of 4 hours.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 2 days
- Number of animals:
- 6
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 4h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 4h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 4 h
- Score:
- 0.2
- Reversibility:
- fully reversible
- Other effects:
- Slight erythema was observed in 4 animals after 4 hours. All signs of irritation had disappeared at 24 hours.
Primary Dermal irritation Index (as sum of mean scores/3) is determined to be 0.2. - Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- 4-(1,1,3,3-tetramethylbutyl)phenol is considered to be slightly irritant with a primary dermal irritation index of 0.2.
- Executive summary:
In a primary dermal irritation study, six New Zealand albino rabbits were dermally exposed to 0.5 ml of 4-(1,1,3,3-tetramethylbutyl)phenol (89%) for 4 hours to a 1.5 inch sized area of the rabbits back and side. Animals then were observed for 48 hours. Slight erythema was observed in 4 animals after 4 hours. All signs of irritation had disappeared at 24 hours. Primary Dermal irritation Index (as sum of mean scores/3) is determined to be 0.2.
In this study, octylphenol is considered to be slightly irritating to the skin of rabbits based under the conditions of this study.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1984-05-23 to 1984-06-12
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Small White Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 2.0 - 2.4 kg
- Housing: single housing in stainless steel cages
- Diet (e.g. ad libitum): Ssniff K4 complete feed for rabbits, ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum, supplied by Gelsenwasser, Wasserwerk Haltern, Germany
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g applied to 6 scm - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² of shaved skin of the dorsal and lateral parts of the trunk of the animals
- % coverage: not mentioned
- Type of wrap if used: on the application area a mull patch (2,5 x 2,5 cm) was placed, which was covered with a polyethylen film (6 x 6 cm). The application area was then immobilised with an elastic dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with aqua dest.
- Time after start of exposure: 4 hours
SCORING SYSTEM: according OECD method (evaluation according to VCI scoring scheme; edema were scored according 79/831/EWG (Annex VI) - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 5.54
- Max. score:
- 6.33
- Reversibility:
- not fully reversible within: 14 days
- Irritant / corrosive response data:
- AVERAGE SCORE (according 76/831/EEC)
- Erythema: 3.72
- Edema: 2.00
- Necroses after 4h - Other effects:
- Yellowish-brown coloration and necrosis with induration occured after 24-72 hours. After 48 h parchment-like application area.
Later on: 6 days incrustations of the application area; days 8-10 new very thin burnish skin. - Interpretation of results:
- highly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced a primary irritation index of 5.54/8 and was classified as a corrosive to rabbit skin according to the OECD 404 classification scheme.
- Executive summary:
In a primary dermal irritation study according to OECD 404, Small White Russian rabbits (3/sex) were dermally exposed to 0.5 g of wet Octylphenol PT for 4 hours to 2.5 x 2.5 cm body surface area. Animals then were observed for 14 days. Irritation was scored by the method of OECD 404 and evaluated according the VCI evaluation scheme.
The test material produced a primary irritation index of 5.54/8. Severe erythema was observed in all animals after 24 h. Necrosis were formed after 4 h. In two out of six animals this effect was not fully reversible yielding scars at day 14. Octylphenol PT was classified as highly irritating.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- In accordance with Regulation (EC) 1907/2006 Annex XI (1.5) and the relevant ECHA guidance documents, the substances detailed in the table below are grouped for the purposes of read across to reduce the need for unnecessary repeat testing on the basis that the substances are similar on the basis of a common functional groups.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 4 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: (superficial) necrosis
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 4 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- primary dermal irritation index (PDII)
- Score:
- 4.5
- Remarks on result:
- other: calculated as "Total Sum/ 2"
- Irritant / corrosive response data:
- Raw data will be retained on file in the Bio/dynamics Archives.
Dermal Scores - 4 and 48 Hours:
Time Interval Observation Animal No. And Sex (M=male, F=female) N=Necrosis
391M 392F 395M 398F 403M 405M
4 hours Erythema 2 2 2 2 2 2
Edema 1 1 2 2 2 2
48 hours Erythema 2 4Nb 4N 2 4Nb 4Nb
Edema 2 2 2 2 2 2
Nb = Superficial necrosis - Conclusions:
- The read across for 4-tert-octylphenol (CAS: 140-66-9); is based upon the analogous substances to which basic form, degree of substitution of functional groups is not considered to effect the proposed read across for the endpoint of skin irritation. Based on the information available for the read across substances, the substance is expected to cause skin irritation.
Referenceopen allclose all
Individual skin reactions
Skin reaction |
Observation time |
Individual Scores – Rabbit Number and Sex (Bodyweight Kg)
|
|
|
||
11 Male (2.30) |
74 Female (2.60) |
78 Male (2.70) |
Total |
|||
Erythema/eschar formation |
1 h |
1 |
1 |
1 |
(3) |
|
|
24 h |
1 |
1 |
1 |
3 |
|
|
48 h |
1 |
1 |
1 |
(3) |
|
|
72 h |
0 |
1 |
1 |
2 |
|
|
7 days |
0 |
0 |
0 |
(0) |
|
Oedema formation |
1 h |
1 |
2 |
1 |
(4) |
|
|
24 h |
1 |
1 |
0 |
2 |
|
|
48 h |
1 |
1 |
0 |
(2) |
|
|
72 h |
0 |
0 |
0 |
0 |
|
|
7 days |
0 |
0 |
0 |
(0) |
|
Sum of 24 and 72-Hour readings (S): 7 |
||||||
Primary Irritation Index (S/6): 7/6 = 1.2 |
||||||
Classification: Mild irritant |
( ) = total values not used for calculation of primary irritation index
Individual daily and individual mean scores for demral irritation following 4 -hour exposure required for EEC labelling regulations
Skin reaction |
Reading (h) |
Individual Scores – Rabbit Number and Sex (Bodyweight Kg)
|
||
11 Male (2.30) |
74 Female (2.60) |
78 Male (2.70) |
||
Erythema/eschar formation |
24 |
1 |
1 |
1 |
|
48 |
1 |
1 |
1 |
|
72 |
0 |
1 |
1 |
Total |
|
2 |
3 |
3 |
Mean Score |
|
0.7 |
1.0 |
1.0 |
Oedema formation |
24 |
1 |
1 |
0 |
|
48 |
1 |
1 |
0 |
|
72 |
0 |
0 |
0 |
Total |
|
2 |
2 |
0 |
Mean Score |
|
0.7 |
0.7 |
0.0 |
Special notations were made of necrosis, eschar or other evidence of irreversibel alteration of tissue structure.
Table #: Irritant/corrosive response data for each animal at each observation time of each animal from the test
Score at time point / Reversibility |
Erythema |
Edema |
male: 1 / 2 / 3 female : 4 / 5 / 6 |
male: 1 / 2 / 3 female : 4 / 5 / 6 |
|
60 min |
2 / 2 / 3 / 4 / 3 / 3 |
3 / 2 / 2 / 2 / 2 / 2 |
24 h |
4 / 4 / 4 / 4 / 4 / 4 |
2 / 3 / 3 / 2 / 2 / 2 |
48 h |
4 / 4 / 3 / 4 / 4 / 3 |
2 / 3 / 3 / 2 / 2 / 2 |
72 h |
4 / 3 / 3 / 4 / 4 / 3 |
2 / 2 / 1 / 1 / 1 / 1 |
Average 24h, 48h, 72h |
3.72 |
2.00 |
Reversibility*) |
n.c. (2 animals) |
c. |
Average time (unit) for reversion |
14 d |
8 d |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Special notations were made of necrosis, eschar or other evidence of irreversibel alteration of tissue structure.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Documentation insufficient for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Single instillation (0.1 ml) into right eye of 6 albino rabbits. Left eye untreated served as control.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: albino rabbits
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Duration of treatment / exposure:
- single instillation of 0.1 ml
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Other effects:
- Observations: severe corneal, iridial and conjunctival effects persisting through the 7th day
- Interpretation of results:
- no data
- Remarks:
- Migrated information
- Conclusions:
- Octylphenol is evaluated to cause irreversible damage to the eye under the test conditions of the study.
- Executive summary:
- In a primary eye irritation study, 0.1ml of p-octylphenol (89%) as supplied was instilled into the conjunctival sac of the right eye of albino rabbits (6 animals) in a single instillation. Left eye served as control. Animals then were observed for 7 days. Irritation was scored using the scale for ocular lesions. Severe corneal, iridial and conjunctival effects were observed that persisted through the 7th day.
In this study, octylphenol causes severe damage to the eye. Observation period was 7 days. For a classification as category 1 according CLP-Regulation (EC) No 1272/2008 an observation period of 21 days would be necessary.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-05-29 to 1984-06-19
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Small White Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 1.85 - 2.68 kg
- Housing: conventional, singly in stainless steel cages
- Diet (e.g. ad libitum): K4 complete feed for rabbits ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 1, 24, 48 and 72 hours, and 6, 7, 9, 14, 16 and 21 days after application
- Number of animals or in vitro replicates:
- 3 male + 3 female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): 24 hours after application, the treated eyes were checked for cornea damage with sodium fluoresceine solution and then rinsed with warm physiological saline
SCORING SYSTEM: according to guideline
TOOL USED TO ASSESS SCORE: ophtmalic lamp, fluorescein 72 hours after administration - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 38.4
- Reversibility:
- not fully reversible within: 21 days
- Irritant / corrosive response data:
- AVERAGE SCORE according 79/831/EEC Annex VI
- Cornea: 1.44
- Iris: 1.00
- Conjuntivae (Redness): 3.00
- Conjuntivae (Chemosis): 1.44 - Other effects:
- 24 hours after treatment all animals showed redness and evident chemosis of conjunctiva. Increased chemosis was seen at the following examinations: exudation, necrosis and white settlings in the conjuctival sac. The iris was reddish discoloured. All animals showed cornea pannus and extreme circumcorneal injection after 6 days.
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Octylphenol PT is moderate irritating to the eye with a primary irritation index of 38.42/110. Severe ocular lesions occur after 72h. Due to the delayed effect and the persistency of the lesions the substance is classified Category 1 “irreversible effects on the eye”.
- Executive summary:
In a primary eye irritation study, 0.1 g of p-(1,1,3,3-Tetramethylbutyl)-phenol was instilled into the conjunctival sac of the right eye of Small White Russia rabbits (3/sex) for 24 hours. After application, the treated eyes were checked for cornea damage and rinsed with warm physiological saline. Animals then were observed for 21 days. Irritation was scored by the method of Draize (1959).
24 hours after treatment all animals showed redness and evident chemosis of conjunctiva. Increased chemosis was seen at the following examinations: exsudation, necrosis and white settlings in the conjuctival sac. The iris was reddish discoloured. All animals showed cornea pannus and extreme circumcorneal injection after 6 days.
In this study, p-(1,1,3,3-Tetramethylbutyl)- is moderately irritating to the eye based on an irritation index of 38.42/110. Severe ocular lesions occur after 72h. Due to this delayed effect and the persistency of these lesions the substance is classified Category 1 "irreversible effects on the eye” according CLP-Regulation (EC) No 1272/2008.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 28 January 1991 - 29 January 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study, one animal is sufficient if test indicate the substance to be a severe irritant
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.95 kg
- Housing: individually in a suspended metal cage
- Diet (e.g. ad libitum): ad libitum; Spillers Rabbit Diet, Dalgety Agriculture Ltd., Almondsbury, Bristol
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 22 °C
- Humidity (%): 55 - 60 %
- Air changes (per hr): 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye remained untreated for control purposes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml (approx. 60 mg) ground before treatment - Duration of treatment / exposure:
- Assessment of ocular damage/irritation was made approximately 1 hour
and 24 hours following treatment - Number of animals or in vitro replicates:
- one
- Details on study design:
- TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by use of the light source from a standard ophthalmoscope.
The animal was killed for humane reasons immediately after the 24-hour observation in accordance with Home Office guidelines. No further animals were treated. - Irritant / corrosive response data:
- For scoring results see table 1.
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance produced a maximum total score of 63.0 and was considered to be at least a SEVERE IRRITANT (CLASS 6 ON A 1 TO 8 SCALE) to the rabbit eye according to a modified Kay and Calandra classification system (based on one rabbit).
- Executive summary:
In a primary eye irritation study according OECD 405, 0,1 ml of 4-(1,1,3,3-TETRAMETHYLBUTYL)-PHENOL was instilled into the conjunctival sac of the right eye of one male New Zealand rabbit for 24 hours. The animal was observed for 24 hours. Irritation was scored by the method of Kay and Calandra.
The test material produced positive criteria in the treated rabbit according to the EEC labelling regulations and was considered to be IRRITANT to the rabbit eye. It is reasonable to assume the symbol "Xi" and highest risk phrase R 41 "RISK OF SERIOUS DAMAGE TO EYES" are required.
Referenceopen allclose all
results are shown in tabular form in attachment "7.3.2 summary of results"
Table #: Irritant/corrosive response data for each animal at each observation time of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 male: 1 / 2 / 3 female : 4 / 5 / 6 |
Max. score: 2 male: 1 / 2 / 3 female : 4 / 5 / 6 |
Max. score: 3 male: 1 / 2 / 3 female : 4 / 5 / 6 |
Max. score: 4 male: 1 / 2 / 3 female : 4 / 5 / 6 |
|
60 min |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
1 / 2 / 1 / 2 / 2 / 2 |
1 / 2 / 2 / 1 / 2 / 1 |
24 h |
1 / 1 / 1 / 1 / 1 / 2 |
1 / 1 / 1 / 1 / 1 / 1 |
2 / 2 / 3 / 3 / 3 / 3 |
2 / 2 / 3 / 3 / 3 / 3 |
48 h |
1 / 1 / 1 / 1 / 1 / 2 |
1 / 1 / 1 / 1 / 1 / 1 |
2 / 2 / 3 / 2 / 3 / 3 |
2 / 2 / 3 / 3 / 3 / 3 |
72 h |
2 / 2 / 2 / 2 / 2 / 2 |
1 / 1 / 1 / 1 / 1 / 1 |
1 / 2 / 2 / 3 / 3 / 3 |
1 / 1 / 2 / 1 / 1 / 1 |
Average 24h, 48h, 72h |
1.44 |
1.00 |
2.50 |
2.17 |
Area effected |
|
|
|
|
Maximum average score (including area affected, max 110) |
|
|
|
|
Reversibility*) |
n. |
n. |
n. |
c. |
Average time (unit) for reversion |
- |
- |
- |
21 |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
T A B L E 1 |
INDIVIDUAL SCORES AND TOTAL SCORES FOR OCULAR IRRITATION |
||
Rabbit Number and Sex |
IPR = 3 |
179 Male |
|
(Bodyweight Kg) |
2.95 |
||
Time After Treatment |
1 hour |
24 hours |
|
CORNEA |
|||
E = Degree of Opacity |
1 |
2 |
|
F = Area of Opacity |
4 |
4 |
|
Score (E x F) x 5 |
20 |
40 |
|
IRIS |
|||
D |
1 |
1 |
|
Score (D x 5) |
5 |
5 |
|
CONJUNCTIVAE |
|||
A = Redness |
2 |
2 |
HWS1 |
B = Chemosis |
2 |
4 |
|
C = Discharge |
3 |
3 |
B1 |
Score (A + B + C) x 2 |
14 |
18 |
|
Total Score |
39 |
63 |
|
IPR = initial pain reaction H = haemorrhage of conjunctival membrane B1 = blood stained discharge |
|||
S1 = sloughing of conjunctival surface W = white appearance of nictitating membrane |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Additional information
Skin irritation:
In a primary dermal irritation study according to OECD 404, 3 New Zealand White rabbits were dermally exposed to 0.5 g of 4 -(1,1,3,3-tetramethylbutyl)phenol (98.97% GC) in distilled water for 4 hours to 2.5 x 2.5 cm of body surface area (Safepharm Laboratories Ltd. 1991 (Report 47/1579, GLP). Residual substance was removed. Animals then were observed for 7 days. Irritation was scored according to Draize (1959). Very slight erythema was noted at all treated skin sites one, 24 and 48 hours after patch removal and at two treated skin sites at the 72 hour observation. Slight edema was noted at one treated skin site one hour after patch removal. Very slight edema was noted at the two remaining treated skin sites at this time and at two treated skin sites at the 24 and 48 hour observations. All treated skin sites appeared normal seven days after treatment. 4-(1,1,3,3-tetramethylbutyl)phenol is a mild dermal irritant based on a primary irritation index of 1.2.
This result was supported by another primary dermal irritation study (Rohm & Haas, 1973 (OTS 84003A). Six New Zealand albino rabbits were dermally exposed to 0.5 ml of 4-(1,1,3,3-tetramethylbutyl)phenol (89%) for 4 hours to a 1.5 inch sized area. Animals were observed for 48 hours. Slight erythema was observed in 4 animals after 4 hours. All signs of irritation had disappeared within 24 hours. Primary Dermal irritation Index (as sum of mean scores/3) is determined to be 0.2. In this study, octylphenol is considered to be slightly irritating to the skin of rabbits. The test compound was characterizued as a mixture of p-octylphenol 89%, o-octylphenol 2%, dioctylphenol 5%, other isomers 3% and phenol <1%.
A more severe result was reported in a second dermal irritation study according to OECD 404 (Hüls, 1984 (Report 0225)). Three Small White Russian rabbits per sex were dermally exposed to 0.5 g of wet Octylphenol PT for 4 hours to 2.5 x 2.5 cm body surface area. Animals then were observed for 14 days. Irritation was scored by the method of OECD 404 and evaluated according the VCI evaluation scheme. The test material produced a primary irritation index of 5.54/8. Severe erythema was observed in all animals after 24 h. Necrosis were formed after 4 h. In two out of six animals this effect was not fully reversible yielding scars at day 14. Octylphenol PT was classified as highly irritating causing irreversible damage. The test substance was characterized as p-(1,1,3,3-Tetramethylbutyl)-phenol/Mixture with other isometric branched monooctylphenols.
In a primary dermal irritation study young adult New Zealand White rabbits (4 males, 2 females) were dermal exposed to 0.5 g of Octylphenol in saline for 4 hours to the back from the scapular to the lumber region (Biodynamics, 1982 (Report 4214-82)). Animals were observed for 48 h. Irritation was scored by the method of Draize. The primary irritation index is 4.5. Four of six animals exhibited evidence of tissue destruction (necrosis) at 48 hours. In this study, Octylphenol is corrosive to the skin but the observation period was not long enough to assess the reversibility of the effect.
The last two studies are considered not to be adequate due to the poor characterization of the test substance. For the purpose of risk assessment the GLP guidance study conducted by Safepharm Lab. Ltd. (1991) is considered most reliable. On base of this study 4 -tert-octylphenol is considered irritant to skin (Skin Irrit. 2).
Eye irritation:
In a primary eye irritation study, 0.1 g of p-(1,1,3,3-Tetramethylbutyl)-phenol was instilled into the conjunctival sac of the right eye of Small White Russia rabbits (3/sex) for 24 hours (Hüls AG, 1984 (Report 0226)). After application, the treated eyes were checked for cornea damage and rinsed with warm physiological saline. Animals then were observed for 21 days. Irritation was scored by the method of Draize (1959). 24 hours after treatment all animals showed redness and evident chemosis of conjunctiva. Increased chemosis was seen at the following examinations: exsudation, necrosis and white settlings in the conjuctival sac. The iris was reddish discoloured. All animals showed cornea pannus and extreme circumcorneal injection after 6 days. In this study, p-(1,1,3,3-Tetramethylbutyl)- is moderately irritating to the eye based on an irritation index of 38.42/110. Severe ocular lesions occur after 72h.
This result was confirmed by a second OECD 405 study (Safepharm Laboratories Ltd. , 1991 (Report 47/1580)). 0.1 ml of 4-(1,1,3,3-TETRAMETHYLBUTYL)-PHENOL was instilled into the conjunctival sac of the right eye of one male New Zealand rabbit for 24 hours. The animal was observed for 24 hours. Irritation was scored by the method of Kay and Calandra. The test material produced positive criteria in the treated rabbit according to the EEC labelling regulations and was considered to be a severe irritant.
As part of a poorly documented non-guideline study covering several endpoints (Rohm & Haas, 1973) 0.1ml of p-octylphenol (89%) was instilled into the conjunctival sac of the right eye of albino rabbits (6 animals) in a single instillation. Animals were observed for 7 days. Irritation was scored using the scale for ocular lesions. Severe corneal, iridial and conjunctival effects were observed that persisted through the 7th day. Octylphenol causes severe damage to the eye.
Due to the delayed effect and the persistency of lesions the substance is considered to cause irreversible damage on the eye and classification as Category 1 according CLP-Regulation (EC) No 1272/2008 is concluded.
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: corrosive
Justification for classification or non-classification
Based on a primary irritation index of 1.2 p-tert-octylphenol is calssified Skin Irrit. 2.
Due to the delayed effect and the persistency of lesions the substance is considered to cause irreversible damage on the eye and classification as Category 1 according CLP-Regulation (EC) No 1272/2008 is concluded.
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