Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 201-604-9 | CAS number: 85-42-7
- 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 irritation: Slightly irritating
Eye irritation: Causes serious 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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: FHSA
- Principles of method if other than guideline:
- 24 hour exposure period on abraded and intact skin. Treated sites examined for reaction to treatment 24 and 72 hours following exposure.
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): TK 10 496
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: In-house breeding
- Age at study initiation: 12 - 15 weeks
- Weight at study initiation: 2.5 - 2.7 kg
- Housing: Individually caged
- Diet (e.g. ad libitum): Styles-Oxoid commercial rabbit diet, ad libitum
- Water (e.g. ad libitum): Sterile filtered water, ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21 deg C
- Humidity (%): 50 - 70%
- Photoperiod (hrs dark / hrs light): 10 hours light / 14 hours dark cycle - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: 50% (aq) polyethylene glycol
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.0 mL (500 mg test substance)
- Concentration (if solution): 10 g test substance mixed with 11 mL 50% (aq) polyethylene glycol - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 24 and 72 hours an 6 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Test sites: One abraded, one intact site / animal
- Type of wrap if used: Gauze pad covered with aluminium foil held in place by self adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize scale - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Intact skin
- Remarks:
- FHSA test - observations at 24 and 72 hours only
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Intact skin
- Remarks:
- FHSA test - observations at 24 and 72 hours only
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Intact skin
- Remarks:
- FHSA test - observations at 24 and 72 hours only
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Intact skin
- Remarks:
- FHSA test - observations at 24 and 72 hours only
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Intact skin
- Remarks:
- FHSA test - observations at 24 and 72 hours only
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Intact skin
- Remarks:
- FHSA test - observations at 24 and 72 hours only
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Intact skin
- Remarks:
- FHSA test - observations at 24 and 72 hours only
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Intact skin
- Remarks:
- FHSA test - observations at 24 and 72 hours only
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Intact skin
- Remarks:
- FHSA test - observations at 24 and 72 hours only
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Intact skin
- Remarks:
- FHSA test - observations at 24 and 72 hours only
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Intact skin
- Remarks:
- FHSA test - observations at 24 and 72 hours only
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Intact skin
- Remarks:
- FHSA test - observations at 24 and 72 hours only
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: expert judgment
- Conclusions:
- Primary skin irritation has been investigated according to FHSA test methods. The substance was slightly irritating to the skin of the albino rabbit.
- Executive summary:
Primary skin irritation has been investigated according to FHSA test methods with 24 hours exposure to intact and abraded skin. The substance was slightly irritating to the skin of the albino rabbit.
Exposure was for a 24 hour period in contrast with 4 hours required by current OECD/EU test methods. However, the information obtained clearly demonstrate the substance to be only slightly irritating and classification as a skin irritant would not be required under the EU/GHS classification scheme.
Reference
Intact skin |
||||
Animal No. |
Erythema |
Oedema |
||
24 hours |
72 hours |
24 hours |
72 hours |
|
11 M |
0 |
0 |
1 |
0 |
13 M |
0 |
0 |
0 |
0 |
15 M |
0 |
0 |
1 |
0 |
12 F |
0 |
0 |
2 |
0 |
14 F |
0 |
0 |
0 |
0 |
16 F |
0 |
0 |
0 |
0 |
Mean |
0.0 |
0.33 |
Abraded skin |
||||
Animal No. |
Erythema |
Oedema |
||
24 hours |
72 hours |
24 hours |
72 hours |
|
11 M |
1 |
0 |
2 |
1 |
13 M |
1 |
0 |
0 |
0 |
15 M |
1 |
0 |
1 |
0 |
12 F |
0 |
0 |
2 |
0 |
14 F |
1 |
0 |
0 |
0 |
16 F |
1 |
0 |
1 |
0 |
Mean |
0.42 |
0.58 |
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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: FHSA
- Principles of method if other than guideline:
- Test substance administered to the eye of 6 rabbits. Treated eyes of 3 rabbits washed after 30 seconds. Reaction assessed after 1, 24, 48 and 72 hours, 6, 10 and 14 days
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report):TK 10 946
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: In-house breeding
- Age at study initiation: 12 - 15 weeks
- Weight at study initiation: 2.5 - 2.7 kg
- Housing: Individually caged
- Diet (e.g. ad libitum): Styles-Oxoid commercial rabbit diet, ad libitum
- Water (e.g. ad libitum): Sterile filtered water, ad libitum
- Acclimation period: One week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21 deg C
- Humidity (%): 50 - 70%
- Photoperiod (hrs dark / hrs light): 10 hours light / 14 hours dark cycle - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- Single administration. The eyes of 3 animals washed 30 seconds after administration
- Observation period (in vivo):
- 1, 24, 48 and 72 hours, 6, 10 and 14 days
- Number of animals or in vitro replicates:
- 6, 3 unwashed and 3 washed
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, 3 rabbits, 200 mL warm water
- Time after start of exposure: 30 seconds
SCORING SYSTEM: Draize scale
TOOL USED TO ASSESS SCORE: fluorescein staining to aid visualisation of corneal lesions - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 6 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 6 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 6 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 6 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 6 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 6 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 6 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 6 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 6 days
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Primary eye irritation has been investigated in the rabbit. Hexahydrophthalic anhydride causes serious eye damage.
- Executive summary:
Acute eye irritation has been investigated in the rabbit following administration of a single dose and following FHSA test methods, which are similar to current OECD test methods. Hexahydrophthalic anhydride causes serious eye damage.
Reference
Unwashed
|
Animal Number: 11 |
|||||||
|
|
Ocular reaction |
||||||
Region of eye |
Parameter |
Hours |
Days |
|||||
|
|
1 |
24 |
48 |
72 |
6 |
10 |
14 |
|
Discharge: |
2 |
2 |
3 |
3 |
2 |
|
|
Conjunctivae: |
Chemosis: |
2 |
2 |
2 |
2 |
4 |
|
|
|
Redness: |
2 |
3 |
3 |
3 |
2 |
|
|
Iris: |
Inflammation: |
0 |
1 |
1 |
1 |
1 |
|
|
Cornea: |
Opacity: |
2 |
1 |
1 |
1 |
2 |
|
|
|
Area: |
4 |
4 |
4 |
4 |
4 |
|
|
Unwashed
|
Animal Number: 13 |
|||||||
|
|
Ocular reaction |
||||||
Region of eye |
Parameter |
Hours |
Days |
|||||
|
|
1 |
24 |
48 |
72 |
6 |
10 |
14 |
|
Discharge: |
3 |
3 |
3 |
3 |
2 |
|
|
Conjunctivae: |
Chemosis: |
2 |
3 |
3 |
3 |
3 |
|
|
|
Redness: |
2 |
3 |
3 |
3 |
3 |
|
|
Iris: |
Inflammation: |
0 |
1 |
1 |
1 |
1 |
|
|
Cornea: |
Opacity: |
2 |
1 |
1 |
1 |
2 |
|
|
|
Area: |
4 |
4 |
4 |
4 |
3 |
|
|
Unwashed
|
Animal Number: 12 |
|||||||
|
|
Ocular reaction |
||||||
Region of eye |
Parameter |
Hours |
Days |
|||||
|
|
1 |
24 |
48 |
72 |
6 |
10 |
14 |
|
Discharge: |
2 |
3 |
3 |
3 |
3 |
|
|
Conjunctivae: |
Chemosis: |
3 |
3 |
2 |
2 |
3 |
|
|
|
Redness: |
2 |
3 |
3 |
3 |
3 |
|
|
Iris: |
Inflammation: |
0 |
1 |
1 |
1 |
1 |
|
|
Cornea: |
Opacity: |
2 |
1 |
1 |
2 |
2 |
|
|
|
Area: |
4 |
4 |
4 |
3 |
3 |
|
|
Washed
|
Animal Number: 15 |
|||||||
|
|
Ocular reaction |
||||||
Region of eye |
Parameter |
Hours |
Days |
|||||
|
|
1 |
24 |
48 |
72 |
6 |
10 |
14 |
|
Discharge: |
2 |
2 |
2 |
1 |
0 |
0 |
0 |
Conjunctivae: |
Chemosis: |
2 |
3 |
2 |
2 |
1 |
0 |
0 |
|
Redness: |
2 |
3 |
3 |
3 |
3 |
3 |
1 |
Iris: |
Inflammation: |
1 |
1 |
1 |
0 |
0 |
0 |
0
|
Cornea: |
Opacity: |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
Area: |
4 |
4 |
4 |
4 |
4 |
2 |
1
|
Washed
|
Animal Number: 14 |
|||||||
|
|
Ocular reaction |
||||||
Region of eye |
Parameter |
Hours |
Days |
|||||
|
|
1 |
24 |
48 |
72 |
6 |
10 |
14 |
|
Discharge: |
3 |
3 |
2 |
1 |
0 |
1 |
0 |
Conjunctivae: |
Chemosis: |
3 |
3 |
2 |
2 |
1 |
1 |
1 |
|
Redness: |
2 |
3 |
3 |
3 |
3 |
3 |
3 |
Iris: |
Inflammation: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Cornea: |
Opacity: |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
Area: |
4 |
4 |
4 |
3 |
3 |
1 |
1 |
Washed
|
Animal Number: 16 |
|||||||
|
|
Ocular reaction |
||||||
Region of eye |
Parameter |
Hours |
Days |
|||||
|
|
1 |
24 |
48 |
72 |
6 |
10 |
14 |
|
Discharge: |
2 |
3 |
2 |
1 |
0 |
0 |
0 |
Conjunctivae: |
Chemosis: |
2 |
2 |
2 |
1 |
0 |
0 |
0 |
|
Redness: |
2 |
3 |
3 |
3 |
3 |
3 |
3 |
Iris: |
Inflammation: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Cornea: |
Opacity: |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
Area: |
3 |
4 |
2 |
2 |
2 |
1 |
1 |
Unwashed
|
||||
Animal Number |
Conjunctival Redness
|
Conjunctival Chemosis |
Iris Inflammation |
Corneal Opacity
|
11 13 12 |
3.0 3.0 3.0 |
2.0 3.0 2.3 |
1.0 1.0 1.0 |
1.0 1.0 1.3
|
The mean score recorded for each animal is the average of the individual scores observed at the 24, 48 and 72 hour examinations. |
Washed
|
||||
Animal Number |
Conjunctival Redness
|
Conjunctival Chemosis |
Iris Inflammation |
Corneal Opacity
|
15 14 16 |
3.0 3.0 3.0 |
2.3 2.3 1.7 |
0.7 0.0 0.0 |
1.0 1.0 1.0
|
The mean score recorded for each animal is the average of the individual scores observed at the 24, 48 and 72 hour examinations. |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Primary skin irritation has been investigated according to FHSA test methods with 24 hours exposure to intact and abraded skin. The substance was slightly irritating to the skin of the albino rabbit. Exposure was for a 24 hour period in contrast with 4 hours required by current OECD/EU test methods. However, the information obtained clearly demonstrate the substance to be only slightly irritating and classification as a skin irritant would not be required under the EU/GHS classification scheme.
Acute eye irritation has been investigated in the rabbit following administration of a single dose and following FHSA test methods, which are similar to current OECD test methods. The substance was determined to be cause serious eye damage.
Justification for classification or non-classification
Classification, Labelling, and Packaging
Regulation (EC) No 1272/2008
The available experimental test
data are reliable and suitable for classification purposes under
Regulation (EC) No 1272/2008. Based on available data on skin and eye
irritation, the test item is not classified as a skin irritant, but is
to be classified as eye damaging cat. 1, H318 (causes serious eye
damage) according to Regulation (EC) No 1272/2008 (CLP), as amended for
the tenth time in Regulation (EU) No 2017/776.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
