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EC number: 265-634-4 | CAS number: 65212-77-3
- 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 studies in rabbits were performed to evaluate irritating or corrosive properties of the test material to skin
or eyes (OECD guideline 404 and Fed.Reg 38. No 187). Application of the test substance did not provoke skin irritation. Treatment of rabbits eyes caused slight to moderate conjuctival irritation. All reaction on skin and eyes has resolved within 8 days or were below treshold of regualtion. Therefore, the substance is considered to be non-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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- occlusive conditions, 72 h reading missing, 8-day observation period), limited data to test substance
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occlusive conditions, 72 h reading missing
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- Type of cage: Cage made of stainless steel with wire mesh walk floors, floor area: 40 cm x 51 cm
No. of animals per cage: 1
Animal identification: Ear tattoo (= animal No.)
Room temperature: 20 - 26°C
Humidity: Conventional (about 30 - 70%)
Day/night rhythm: 12 h/12 h (6.00 - 18.00 hours/18.00 - 6.00 hours)
Bedding: No bedding in the cages; sawdust in the waste trays.
Diet: Ovator Solikanin 4 mm; Muskator-Werke Duesseldorf, FRG (about 130 g per animal per day)
Drinking water: About 250 ml per animal per day: demineralized water (Monday-Friday), tap water (weekends).
Mean weight of male animal: 2.64, of female animal 2.39 kg.
Acclimatization period: About 8 days before the beginning of the study in the skin laboratory; same housing conditions as during the study. - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- other: untreated skin of the same animal
- Amount / concentration applied:
- 50% suspension (app. 0.5 g of the test substance is applied)
- Duration of treatment / exposure:
- 3 minutes and 4 hours
- Observation period:
- 8 days
- Number of animals:
- 2 (one male, one female)
- Details on study design:
- Clipping of the fur: At least 15 hours before the beginning of the study.
Application area: 2.5 cm x 2.5 cm
Appl. volume: The test patch (2.5 x 2.5 cm) is covered with an about 0.5 mm layer of the 50% suspension (thus about 0.5 g of the test substance is applied; because of the natural moisture of the skin, distilled water is used to prepare the suspensions so that the test can be carried out under as physiological conditions as possible).
Appl. site: Upper third of the back or flanks.
Removal of the test substance: At the end of the exposure period with Lutrol and Lutrol/water (1 :1).
Readings: 15 - 30 minutes after removal of the test patches and 24 h, 48 h, 8 d after the beginning of application.
Assessment according to J.H. Draize: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. In Dermal Toxicity pp. 46 - 59, 1959. Austin, Tex.: Association of Food and Drug Officials of the United States, Texas, State Department of Health. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 3-min and 4-h application
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: 3-min and 4-h application
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritant / corrosive response data:
- No effects were observed 8 days after the treatment.
- Other effects:
- No other effects.
- Interpretation of results:
- GHS criteria not met
Reference
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Draize test with an observation period of 8 days, limited data to test substance, source/breeder not mentioned, ages of animals not documented
- Qualifier:
- according to guideline
- Guideline:
- other: Fed. Reg. 38, No. 187, § 1500.42, p. 27019, Sept. 27, 1973
- Principles of method if other than guideline:
- Draize Test
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- No. of animais per cage: 1
Room temperature: 20 - 26°C
Humidity: Conventional (about 30 - 70%)
Day/night rhythm: 12 h/12 h (6.00 - 18.00 hours/18.00 - 6.00 hours)
Diet: Ovator Solikanin 4 mm; Muskator-Werke, Düsseldorf, FRG (about 130 g per animal per day)
Drinking water: About 250 ml per animal per day: demineralized water (Monday - Friday), tap water (Saturday/Sunday).
Acclimatization period: About 8 days before the beginning of the study in the skin laboratory; same housing conditions as during the study.
Mean weight (kg) males 2.99, females 2.57 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- 0.1 ml bulk volume (about 31 mg of the comminuted test substance)
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Appl. site: Conjunctival sac of the right eyelid
Assessment: Based on J. H. Draize: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. In Dermal Toxicity pp. 46 - 59, 1959. Austin, Tex.: Association of Food and Drug Officials of the United States, Texas, State Department of Health.
Readings: 1 h, 24 h, 48 h, 72 h, 8 d after application
Single application to the conjunctival sac of the eyelid; the substance is not washed out - Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 1.17
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 8d
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: post observation period of 8d
- Remarks on result:
- other: shows tendency to normalize within 21d
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Other effects:
- Discharge was observed in three animals at reading 24 h (score 1), in two animals at reading 48 h (score 1) and in one animal at reading 72h (score 1). This was reversible within 8 days.
- Interpretation of results:
- GHS criteria not met
Reference
Table 1: Irritation results
Animal |
Reading |
Cornea Opacity |
Iris |
Conjunctiva |
Additional findings |
|
Redness |
Chemosis |
|||||
1 |
24 h |
0 |
0 |
1 |
0 |
- |
2 |
24 h |
0 |
0 |
2 |
1 |
- |
3 |
24 h |
0 |
0 |
1 |
0 |
- |
4 |
24 h |
0 |
0 |
2 |
1 |
- |
5 |
24 h |
0 |
0 |
1 |
0 |
- |
6 |
24 h |
0 |
0 |
2 |
1 |
- |
1 |
48 h |
0 |
0 |
1 |
0 |
- |
2 |
48 h |
0 |
0 |
1 |
1 |
- |
3 |
48 h |
0 |
0 |
1 |
0 |
- |
4 |
48 h |
0 |
0 |
1 |
0 |
- |
5 |
48 h |
0 |
0 |
1 |
0 |
- |
6 |
48 h |
0 |
0 |
2 |
1 |
- |
1 |
72 h |
0 |
0 |
1 |
0 |
- |
2 |
72 h |
0 |
0 |
0 |
0 |
- |
3 |
72 h |
0 |
0 |
0 |
0 |
- |
4 |
72 h |
0 |
0 |
1 |
0 |
- |
5 |
72 h |
0 |
0 |
1 |
0 |
- |
6 |
72 h |
0 |
0 |
2 |
1 |
- |
1 |
8 d |
0 |
0 |
0 |
0 |
- |
2 |
8 d |
0 |
0 |
0 |
0 |
- |
3 |
8 d |
0 |
0 |
0 |
0 |
- |
4 |
8 d |
0 |
0 |
1 |
0 |
- |
5 |
8 d |
0 |
0 |
0 |
0 |
- |
6 |
8 d |
0 |
0 |
1 |
0 |
- |
mean animal 1 |
24 - 72 h |
0.00 |
0.00 |
1.00 |
0.00 |
|
mean animal 2 |
24 - 72 h |
0.00 |
0.00 |
1.00 |
0.67 |
|
mean animal 3 |
24 - 72 h |
0.00 |
0.00 |
0.67 |
0.00 |
|
mean animal 4 |
24 - 72 h |
0.00 |
0.00 |
1.33 |
0.33 |
|
mean animal 5 |
24 - 72 h |
0.00 |
0.00 |
1.00 |
0.00 |
|
mean animal 6 |
24 - 72 h |
0.00 |
0.00 |
2.00 |
1.00 |
|
mean |
24 - 72 h total |
0.00 |
0.00 |
1.17 |
0.33 |
|
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Procedure and results
Two studies were performed to evaluate irritating potential of the test material to skin or eyes.
In the first study, four rabbits (2/sex/dose) were each administered a single dermal dose of 0.5 g given as 50% suspension of the test substance (BASF SE 1981). Occlusive application of the test material to intact rabbit skin for four hours did not cause any reaction on animals skin.
In a second study, six rabbits were each administered a single ocular dose of 31 mg of the test substance and observed for eight days after instillation (BASF AG 1981c). A single instillation of the test material into the eye of the rabbit elicited slight, transient chemosis and moderate redness of conjunctiva which was not fully reversible within post observation period.
There are no data available about irritation to the respiratory system.
Discussion
Application of the test substance onto skin did not cause corrosion or irritation. Appllication into the conjunctival sac of the eye caused slight to moderate conjuctival irritation. Conjunctival irritation was not reversible within 8 day post observation period but showed tendency to normalize and the score of irritation was below the treshold of regulation.
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 1272/2008. As a result the substance is not considered to be classified for irritation under Regulation (EC) No. 1272/2008, as amended for the thirteenth time in Commission Regulation (EU) 2018/1480 of Oct 4 2018.
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.
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