Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 261-521-9 | CAS number: 58958-60-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8 - 16 Mar 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions. Few details on animal husbandry were given and the analytical purity was not stated.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted Apr 2002
- Deviations:
- yes
- Remarks:
- few details on animal husbandry given, analytical purity not stated
- GLP compliance:
- no
Test material
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.390 kg (no further details given)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- 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: 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 d
Reading time points: 1, 24, 48 and 72 h, and 4, 5, 6 and 7 days - Number of animals:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test material was removed with absorbant paper moistened with distilled water
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 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:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- Slight or well-defined erythema (score 1 or 2) was observed in 3/3 animals from 1 h post-application. At the 24 h reading time point, 2/3 animals had well-defined (score 2) and 1/3 slight erythema (score 1). Slight eythema persisted in 2/3 rabbits until Day 5 and in 1/3 until Day 4. At the 1-hour reading time point 1/3 animals had slight edema (score 2) and 1/3 animals had very slight edema (score 1). In both animals very slight edema (score 1) was noted at the 24-hour reading time point, while the effect had cleared within 48 hours. The erythema and edema had cleared completely by the 6 day-reading time point. One rabbit had dry skin from Day 2 - 7, while another rabbit had dry skin from Day 4 - 7.
Any other information on results incl. tables
Table 1: individual skin irritation scores
Observation time |
Rabbit No. |
|||||
|
1 |
2 |
3 |
|||
|
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
1 h |
1 |
2 |
1 |
0 |
2 |
1 |
24 h |
2 |
1 |
1 |
0 |
2 |
1 |
48 h |
1 |
0 |
1 |
0 |
1 |
0 |
72 h |
1 |
0 |
1 |
0 |
1 |
0 |
4 days |
1 |
0 |
1 |
0 |
1 |
0 |
5 days |
1 |
0 |
0 |
0 |
1 |
0 |
6 days |
0 |
0 |
0 |
0 |
0 |
0 |
7 days |
0 |
0 |
0 |
0 |
0 |
0 |
Mean value 24 + 48 + 72 h |
1.33 |
0.33 |
1.00 |
0 |
1.33 |
0.33 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- CLP: not classified
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.
