Registration Dossier
Registration Dossier
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EC number: 203-953-2 | CAS number: 112-27-6
Endpoint summary
Administrative data
Description of key information
The substance was not considered to be irritating to the skin or the eyes.
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- Six New Zealand White rabbits were dosed with 0.5 mL of test material under an occlusive dressing for a period of 4 hours. After the exposure period skin reactions were scored via the method of Draize.
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Batch no.: TS-3200424
- Appearance: Colorless, transparent viscous liquid
- Purity: 99.82% - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.0-3.0 kg
- Diet: commerical diet (ad libitum)
- Water: municipal water (ad libitum) - Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 6
- Details on study design:
- Male and female animals are dosed with 0.5 mL. The dose is applied to the clipped, intact skin under a gauze patch and is loosely covered with impervious sheeting. The test material is applied to each of 6 rabbits, which are restrained for the 4 h contact period. Excess sample is removed after contact. Skin reaction is scored by the method of Draize at 1 hour, 1 day, 2 days, 3 days and 7 days.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No erythema or eschar formation, no edema formation. Other irritation or effects: none.
- 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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- Six New Zealand White rabbits were dosed with 0.1 mL of test material. The dose was instilled into the lower conjunctival sac of one eye. The eyes were scored according to Draize.
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Batch no.: TS-3200424
- Appearance: Colorless, transparent viscous liquid
- Purity: 99.82% - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.0-3.0 kg
- Diet: commerical diet (ad libitum)
- Water: municipal water (ad libitum) - Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Male and female rabbits are dosed with 0.1 mL. The dose is instilled into the lower conjunctival sac of one eye per animal or is placed directly on the eye. The eyelids are held together for one second. Six eyes are dosed per test volume. The eyes are scored according to Draize for 1 h, 4 h, 24 h, 48 h, 72 h and 7 days after dosing. Fluorescin (1%) staining is used to determine corneal injury before dosing and readings after 1 day.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- GHS criteria not met
Reference
No corneal injury in any of 6 eyes, iritis in 6, minor (transient) conjunctival irritation in 6 (with moderate to substantial discharge in 5) with 0.1 mL; all healed at 24 hours.
Summary of eye scores:
| Observation times | 1 h | 4 h | 24 h | 48 h | 72 h | 7 days | ||
| Animal No. | 1 | 2 | 3 | 4 | 5 | 6 | ||
| Cornea | Opacity | Range | All 0 | All 0 | All 0 | All 0 | All 0 | All 0 |
| Mean | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | ||
| Area | Range | All 0 | All 0 | All 0 | All 0 | All 0 | All 0 | |
| Mean | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | ||
| Iris | Injury | Range | All 1 | 0 - 1 | All 0 | All 0 | All 0 | All 0 |
| Mean | 1.0 | 0.2 | 0.0 | 0.0 | 0.0 | 0.0 | ||
| Conjunctivae | Redness | Range | All 1 | All 1 | All 0 | All 0 | All 0 | All 0 |
| Mean | 1.0 | 1.0 | 0.0 | 0.0 | 0.0 | 0.0 | ||
| Chemosis | Range | 0 - 1 | All 1 | All 0 | All 0 | All 0 | All 0 | |
| Mean | 0.8 | 1.0 | 0.0 | 0.0 | 0.0 | 0.0 | ||
| Discharge | Range | 1 - 3 | All 1 | All 0 | All 0 | All 0 | All 0 | |
| Mean | 2.2 | 1.0 | 0.0 | 0.0 | 0.0 | 0.0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
No skin irritation was found in rabbits when applicated the undiluted test substance under occlusive conditions. No eye irritation was seen, given the test substance undiluted into the eyes of rabbits. Scoring for both endpoints was done according to Draize (BRRC, 1990).
There is one study available that investigates respiratory sensory irritation. In this study the decrease in respiratory rates was determined. The RD50 or concentration of the test substance which produced a 50 percent decrease in respiratory rate, was determined to be 5.14 mg/L, with a 95 confidence interval of 3.77-7.10 mg/L.
Justification for classification or non-classification
Based on the available information classification for skin and eye irritation is not warranted in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.
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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