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EC number: 807-157-1 | CAS number: 129677-93-6
- 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
Skin, rabbit (read-across): not irritating
Eye, rabbit (read-across): not irritating
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:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given. The test substance was applied under occlusive conditions for 24 hours, no experimental 48 h reading was performed, few data were reported.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- exposure period 24 h, occlusive conditions, no experimental 48 h reading performed, few details reported
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required, the untreated site of the same animal served as the control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
Reading time points: 24 and 72 h - Number of animals:
- 6 males
- Details on study design:
- SCORING SYSTEM: Draize scoring system
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #3, #4, #5 and #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
- Irritant / corrosive response data:
- Intact skin:
1/6 animals had slight erythema (score 1 of 4) at the 24-hour reading time point, which had cleared completely by the 72-hour reading time point (see Table 1). No other skin irritation effects were observed in any animals.
Abraded skin:
1/6 animals had slight erythema (score 1 of 4) at the 24-hour reading time point. The skin irritation had cleared within 48 hours. - Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- test substance purity not specified; no reading at 48 hours; observation time only 72 hours
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- test substance purity not specified; no reading at 48 hours; observation time only 72 hours
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: New Zealand males
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and incised
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required, untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Reading time points: 24 and 72 hours - Number of animals:
- 6 males
- Details on study design:
- SCORING SYSTEM: Draize scoring system
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 1.34
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: Since no reading was performed at 48 h, the score for this time point was assumed to be the same as the one observed at 24 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: Since no reading was performed at 48 h, the score for this time point was assumed to be the same as the one observed at 24 h
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 11 - 18 Mar 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The exposure was performed under occlusive conditions, the analytical purity of the test substance was not specified.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occlusive exposure
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated skin site of the same animal served as the control
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Type of wrap if used: occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated site was not washed after patch removal
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritant / corrosive response data:
- 1 hour after exposure, all the animals had slight to well-defined erythema, while 2/3 had very slight to slight edema. These effects gradually reduced in severity. 24 hours after exposure ended, 1/3 animals had very slight erythema and slight edema. the edema persisted until the 48-hour reading time point.All skin irritation effects had cleared completely within 72 hours after the exposure ended.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
Referenceopen allclose all
Table 1: individual erythema and edema scores for intact skin
Observation time |
Rabbit No. |
|||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
24 h |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
48 h |
No experimental data available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption)
|
|||||||||||
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Table 2: calculation of mean scores for intact skin
|
Rabbit No. |
|||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
Mean value 24+48+72 h |
0 |
0 |
0.67 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Table 1: Results of skin irritation study - intact skin
Observation time |
Rabbit no. |
|||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||||
E |
O |
E |
O |
E |
O |
E |
O |
E |
O |
E |
O |
|
24 h |
1 |
0 |
2 |
1 |
2 |
0 |
1 |
0 |
1 |
0 |
2 |
0 |
48 h1 |
1 |
0 |
2 |
1 |
2 |
0 |
1 |
0 |
1 |
0 |
2 |
0 |
72 h |
1 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
2 |
1 |
Mean value |
1.00 |
0.00 |
1.67 |
0.67 |
1.67 |
0.00 |
0.67 |
0.00 |
1.00 |
0.00 |
2.00 |
0.33 |
Table 2: Results of skin irritation study - incised skin
Observation time |
Rabbit no. |
|||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||||
E |
O |
E |
O |
E |
O |
E |
O |
E |
O |
E |
O |
|
24 h |
2 |
0 |
2 |
1 |
2 |
0 |
1 |
0 |
1 |
0 |
2 |
0 |
48 h1 |
2 |
0 |
2 |
1 |
2 |
0 |
1 |
0 |
1 |
0 |
2 |
0 |
72 h |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
2 |
1 |
Mean value |
1.67 |
0.00 |
1.67 |
0.67 |
1.33 |
0.00 |
0.67 |
0.00 |
1.00 |
0.00 |
2.00 |
0.33 |
E: erythema, O: oedema (according to Draize Score)
1 Since no reading was performed at 48 h, the score for this time point was assumed to be the same as the one observed at 24 h
Table 1: Erythema and edema scores for skin irritation of the individual animals at different reading time points:
Observation time |
Rabbit no. |
|||||
1 |
2 |
3 |
||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
1 h |
2 |
2 |
1 |
0 |
1 |
1 |
24 h |
1 |
2 |
0 |
0 |
0 |
0 |
48 h |
0 |
1 |
0 |
0 |
0 |
0 |
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
Mean value 24 + 48 + 72 h |
0.33 |
1.00 |
0 |
0 |
0 |
0 |
Mean value 24 + 48 + 72 h all animals |
0.11 |
0.33 |
|
|
|
|
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 May - 16 Jul 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: The Broekman Institute, Someren, The Netherlands
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: 2693 - 2894 g
- Housing: individually in plastic cages with perforated floors
- Diet: standard animal diet (100 g per day), obtained from Hope Farms, Woerden (LK-01, pellet diameter 4 mm)
- Water: tap-water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 60 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Single eye instillation
- Observation period (in vivo):
- 72 hours (in the absence of any persistent sign of irritation)
Reading time points: 1, 24, 48 and 72 hours after instillation - Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- 2 out of 3 animals showed only slight swelling of the blood-vessels in the conjunctivae 1 hour after instillation. The effects were fully reversible 24 hours after instillation. The fluorescein analysis 24 hours after instillation did not reveal any epithelial damage.
- Other effects:
- Signs of systemic intoxication were not observed.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- test substance purity not specified, methodological differences, only 0.05 mL test substance evaluated, only 24-h reading, only 24-h observation period
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- test substance purity not specified, methodological differences, only 0.05 mL test substance evaluated, only 24-h reading, only 24-h observation period
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: New Zealand
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated left eye served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 mL undiluted test substance - Duration of treatment / exposure:
- single eye instillation
- Observation period (in vivo):
- 24 hours
Reading time points: 2, 6 and 24 h after instillation - Number of animals or in vitro replicates:
- 2 (male)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 2 animals
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 2 animals
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 2 animals
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 2 animals
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- One animal showed mild conjunctival erythema 2 hours after instillation, which disappeared completely within 6 hours.
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The test substance was not irritating in this test, however, observation period was only 24 hours long.
Referenceopen allclose all
Table 1: Results of eye irritation test
Rabbit No. / sex |
Scoring [h] |
Cornea |
Iris |
Conjunctiva |
|
Redness |
Chemosis |
||||
1 / f |
1 |
0 |
0 |
1 |
0 |
|
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
Mean (24, 48, 72 h) |
0 |
0 |
0 |
0 |
|
2 / f |
1 |
0 |
0 |
0 |
0 |
|
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
Mean (24, 48, 72 h) |
0 |
0 |
0 |
0 |
|
3 / f |
1 |
0 |
0 |
1 |
0 |
|
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
Mean (24, 48, 72 h) |
0 |
0 |
0 |
0 |
|
Group mean |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for read-across
There are no available data on the skin and eye irritation effects of Fatty acids C8-10, C8-10 alkyl esters (CAS 129677-93-6). The assessment was therefore based on studies conducted with analogue substances as part of a read across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. For each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13) and within Chapter 5.1 of the CSR.
Skin irritation
CAS 95912-86-0
A skin irritation study was performed with Fatty acids, C8-10, C12-18 alkyl esters (CAS 95912-86-0), according to a protocol similar to OECD guideline 404 (WoE, 1991). 0.5 mL of the test substance was applied to the shaved skin of 3 male rabbits and held in place by an occlusive dressing for 4 hours. 1 hour after exposure, all the animals had slight to well-defined erythema (score 1 – 2), while 2/3 had very slight to slight edema (score 1 – 2). These effects gradually reduced in severity. 24 hours after exposure ended, 1/3 animals had very slight erythema and slight edema. The edema persisted until the 48-hour reading time point. All skin irritation effects had cleared completely within 72 hours after the exposure ended. The mean erythema scores (over 24, 48 and 72 hours) were 0.33, 0 and 0 while the mean edema scores (over 24, 48 and 72 hours) were 1, 0 and 0. The test substance is not considered to be irritating to the skin.
CAS 34316 -64 -8
An acute skin irritation study was performed with hexyl laurate (CAS 34316-64-8) according to a protocol similar to OECD guideline 404 (WoE, 1987). The intact and abraded skin of 6 male New Zealand rabbits was treated with 0.5 mL of the test material (no data on purity) for 24 hours under occlusive conditions. The animals were observed for 72 hours and scoring according to the Draize scoring system was performed 24 and 72 hours after patch removal. Slight to moderate erythema (score 1 - 2) was observed in all animals at both reading time points, with the severity remaining the same at the 72-hour reading time point for 3/6 animals. Slight oedema was noted in 1/6 animals at the 24-hour reading time point, and in 1/6 (a different animal) at the 72-hour reading time point. The skin irritation had cleared within 72 hours for 1/6 animals. The results of the abraded skin sites were comparable, but not taken into account for hazard assessment. To be able to calculate the mean scores, the 48-hour scores were assumed to be the same as those determined 24 h after patch removal (worst case assumption). The mean erythema scores (over 24, 48 and 72 hours) were 1.0, 1.67, 1.67, 0.67, 1.0, and 2.0 while the mean edema scores (over 24, 48 and 72 hours) were 0, 0.67, 0, 0, 0, and 0.33. The test substance is not considered to be irritating to the skin.
CAS 3234-85-3
A skin irritation study was performed according to a protocol similar to OECD guideline 404 with tetradecanoic acid, tetradecyl ester (CAS 3234-85-3) (WoE, 1985). The test substance was applied to the shaved or abraded skin of 6 male rabbits and held under occlusive conditions for 24 hours. The reading time points were 24- and 72 hours after patch removal. 1/6 animals had slight erythema (score 1 of 4) on the intact skin at the 24-hour reading time point, which had cleared completely by the 72-hour reading time point. No other skin irritation effects were observed in any animals (6/6). The results of the abraded skin sites were comparable, but not taken into account for hazard assessment. To be able to calculate the mean scores, the 48-hour scores were assumed to be the same as those determined 24 h after patch removal (worst case assumption). The mean erythema scores (over 24, 48 and 72 hours) were 0, 0.67, 0, 0, 0, and 0 while the mean edema scores (over 24, 48 and 72 hours) were all 0. The test substance is not considered to be irritating to the skin.
Eye irritation
CAS 92044-87-6
An eye irritation study was performed with Fatty acids, coco, 2-ethylhexyl ester (CAS 92044-87-6) according to OECD guideline 405 (Key, 1987). 0.1 mL of the test substance was instilled into the eyes of 3 female New Zealand White rabbits. The animals were observed for 72 hours and scoring according to Draize was performed 1, 24, 48, and 72 hours after application. The eyes were not rinsed. At the 1-hour reading time point 2/3 rabbits had slight conjunctivae (score 1). The effects had cleared completely by the 24-hour reading time point. No effects on the cornea and iris were noted, and no chemosis was reported at any time point in any animal. The mean cornea score and iris score (over 24, 48 and 72 hours) was 0 for all animals, respectively. The mean conjunctivae score and chemosis score (over 24, 48 and 72 hours) was 0 for all animals, respectively. Based on the results of the study, the test substance is not considered irritating to the eyes.
CAS 91031 -48 -0
Fatty acids, C16-18, 2-ethylhexyl esters (CAS 91031-48-0) was examined for its eye irritation potential in a study performed similar to OECD Guideline 405 (Supporting, 1978). 0.05 mL undiluted test substance (no data on purity) was instilled into the right eye of 2 rabbits. One animal showed mild conjunctival erythema 2 hours after instillation, which disappeared completely within 6 hours. 24 hours after instillation, no ocular lesions were observed. All the scores for both rabbits were 0 for cornea, iris, conjunctivae and chemosis effects. Based on the study results, the test substance showed no eye irritating potential.
Overall conclusion for skin and eye irritation
The available data on suitable source substances did not show any skin
or eye irritation effects. Therefore, the target substance Fatty acids
C8-10, C8-10 alkyl esters is not considered to be a skin irritant or an
eye irritant.
Justification for classification or non-classification
According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the analogue concept is applied to Fatty acids C8-10, C8-10 alkyl esters (CAS 129677-93-6), data will be generated from data for reference source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.
The available data on skin and eye irritation do not meet the classification criteria according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.
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