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EC number: 603-923-2 | CAS number: 135590-91-9
- 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
Skin irritation (OECD 404), rabbit: not irritating
Eye irritation (OECD 405), rabbit: 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:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guidelines for Testing of Chemicals "Phototoxicity after cutaneous application" DRAFT Guideline, 14 March 1990
- Deviations:
- not specified
- Principles of method if other than guideline:
- Following systemic or local application chemical substances may produce an increased reactivity of the skin to irradiation with ultraviolet and/or visible light. This phenomenon is called "phototoxicity" or "photoirritancy", arises after the first exposure and is not related with the immune system. The pathogenic reaction is based on a cytotoxic photooxidation of the respective compound on the site of irradiation. Therefore the localization of signs of dermal irritation is limited to the light-exposed area.
- GLP compliance:
- yes
- Species:
- guinea pig
- Strain:
- other: Pirbright-White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF breeding colony
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: 261 g mean
- Housing: in fully air-conditioned rooms in Makrolon cages (Type 4) on soft wood granulate, in groups of 5 animals
- Diet (e.g. ad libitum): Altromin 3112 mixed diet for guinea pigs and rabbits ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least 1 day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- open
- Preparation of test site:
- shaved
- Vehicle:
- other: DAE
- Controls:
- other: solvent control area on each of 5 animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.06 mL
- Concentration (if solution): 20, 10 and 5% in vehicle
VEHICLE
- Concentration (if solution): 40% dimethylacetamid, 30% acetone, 30% ethanol - Duration of treatment / exposure:
- 4, 24 and 48 h (substance remains not removed)
- Observation period:
- 4, 24 and 48 h
- Number of animals:
- 10 females
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm by 8 cm area on the back, subdivided into 4 sites of equal size
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Remarks:
- 20 % test substance
- Basis:
- mean
- Time point:
- other: 4 h
- Score:
- 1.8
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Remarks:
- 20 % test substance
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1.4
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Remarks:
- 20 % test substance
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Remarks:
- 10 % test substance
- Basis:
- mean
- Time point:
- other: 4 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Remarks:
- 10 % test substance
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Remarks:
- 10 % test substance
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0.9
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Remarks:
- 5 % test substance
- Basis:
- mean
- Time point:
- other: 4 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- erythema score
- Remarks:
- 5 % test substance
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Remarks:
- 5 % test substance
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 4, 24, 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritant / corrosive response data:
- Positive reactions were seen on all treated spots in an unequivocal concentration-dependent manner in an incidence of 100 , 100 and 40 % in the three treatment groups, reactions in the form of slight to moderate erythema were mostly pronounced in the highest treatment groups of the 20 and 10 % solutions. In the positive control with 0.02 % 8-methoxypsoralen 4 out of 5 treated animals showed slight erythema.
- Other effects:
- No clinical signs of intoxication were observed at any time during the study. The condition of the animals showed no signs of any disturbances of food consumption or body weight gains.
- Interpretation of results:
- other: phototoxic
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund, conventional breed
- Age at study initiation: approx. 3 - 5 months
- Weight at study initiation: 2.9 - 4.0 kg
- Housing: individually, in fully air-conditioned rooms, separate cages (arranged in a battery)
- Diet: Altromin 2123 maintenance diet - rabbits (Altromin GmbH, Lage/Lippe), ad libitum and hay (approx. 15 g daily)
- Water: deionised, chlorinated water from automatic water dispensers, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 50±20
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: sesame oil
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): moistened
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.35 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48, 72 h
- Number of animals:
- 6 (4 males, 2 females)
- Details on study design:
- TEST SITE
- Area of exposure: 6.25 cm²
- Type of wrap if used: surgical plaster with a 2.5 x 2.5 cm cellulose patch (specially produced by Beiersdorf AG, Hamburg) was fixed onto the shaved skin area of each animal. 0.5 g moistened test substance was applied under each patch. The area was then covered with a semi-occlusive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm tap water
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2. #3, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2. #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- The test substance caused minor effects on the skin of two animals in the form of very slight erythema (grade 1, in one animal only at 1 hour after removal of the test substance). These signs of irritation were completely reversible within 3 days.
- Other effects:
- No clinical signs of systemic toxicity were 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
Referenceopen allclose all
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:
- 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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund, conventional breed
- Age at study initiation: approx. 3 - 5 months
- Weight at study initiation: 3.4 - 4.2 kg
- Housing: in fully air-conditioned rooms, separate cages (arranged in a battery)
- Diet (e.g. ad libitum): Altromin 2123 maintenance diet - rabbits (Altromin GmbH, Lage/Lippe), ad libitum, and hay (approx. 15 g daily)
- Water (e.g. ad libitum): deionised, chlorinated water from automatic
water dispensers, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 50±20
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eyes served as controls
- 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, 72 h
- Number of animals or in vitro replicates:
- 6 (5 females, 1 male)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, physiological saline
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.38
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.83
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- 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: 72 hours
- Irritant / corrosive response data:
- The test substance caused effects in the eyes in the form of conjunctival reddening, chemosis and discharge, inflammation and opacity of the iris, ranging in degree from slight to moderate. All signs of irritation were completely reversible within 72 hours.
- Other effects:
- No clinical signs of systemic toxicity were 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
Reference
Means (24 - 72 hours) of individual eye irritation scores:
Animal # |
Cornea opacity (max. 4) |
Iris (max. 2) |
Conjunctiva redness (max. 3) |
Conjunctiva chemosis (max. 4) |
1 |
0 |
0 |
0.33 |
0 |
2 |
0.33 |
0 |
1.00 |
0 |
3 |
0.33 |
0 |
0.66 |
0 |
4 |
0.66 |
0.33 |
0.66 |
0 |
5 |
0.66 |
0.33 |
1.33 |
1.00 |
6 |
0.33 |
0 |
1.00 |
1.00 |
Mean |
0.38 |
0.11 |
0.83 |
0.33 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
A study on skin irritation was performed in rabbits according to OECD guideline 404 and in compliance with GLP. 0.5 mg of moistened test substance was applied to the shaved skin of six New Zealand White rabbits. The skin was exposed for 4 h under semi-occlusive conditions. Local skin reactions were assessed according to the Draize scoring system 1, 24, 48 and 72 h post administration.
Very slight erythema (grade 1) was observed in 2/6 animals. The effect was observed in one animal at the 24 and 48 h observation time point and in one animal one hour after removal of the test substance only. All effects were fully reversible within 72 h after administration. There were no skin reactions in any other animal. Based on the study results, the test item is not considered irritating to the skin.
Additionally, a study on phototoxicity was performed in guinea pigs at concentrations of 20, 10 and 5% in vehicle, in which the ability of the test substance to induce an increased reactivity of the skin to irradiation with UV and/or visible light was investigated. Positive reactions in the form of slight to moderate erythema, mostly pronounced in the highest treatment groups, were observed on all treated spots in an unequivocal concentration-dependent manner in an incidence of 100, 100 and 40 % in the three treated groups. Incidence in the positive control group was 80 %. No other signs of intoxication were observed. Therefore, the test substance has to be regarded as phototoxic.
Eye irritation
The eye irritating potential of the test item was analysed in New Zealand White rabbits according to OECD guideline 405 and compliant with GLP. A single tests item dose of 100 mg was installed into one eye of each animal, and washed out after 24 h. The other eye remained untreated and served as control. Local irritations of the eye were evaluated according to Draize criteria 1, 24, 48 and 72 h after administration.
The test substance caused effects in the eyes in the form of conjunctival reddening, chemosis and discharge, inflammation and opacity of the iris, ranging in degree from slight to moderate. All signs of irritation were completely reversible within 72 h. Based on these results and under the experimental conditions of the study, the test item was considered not irritating tot the eye.
Justification for classification or non-classification
The available data on skin and eye irritation/corrosion do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 and are therefore conclusive but not sufficient for classification. The test substance has to be regarded as phototoxic.
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