Registration Dossier
Registration Dossier
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EC number: 938-580-0 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well-documented, scientifically acceptable study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
- Principles of method if other than guideline:
- according to Fed. Reg. 38, No. 187, p. 26029, 1973 (Draize test)
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium hydroxide
- EC Number:
- 215-185-5
- EC Name:
- Sodium hydroxide
- Cas Number:
- 1310-73-2
- Molecular formula:
- HNaO
- IUPAC Name:
- sodium hydroxide
- Details on test material:
- Name of test material (as cited in study report): Natronlauge
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: M. Gaukler, 6050 Offenbach
- Weight at study initiation: ca. 2.8 kg
- Housing: During the exposure animals are fixed
- Diet (e.g. ad libitum): Ssniff K, Standard diet for rabbits and guinea pigs of the company INTERMAST GMBH, Soest. No feeding during the exposure
- Water (e.g. ad libitum): Ad libitum. No water available during the exposure
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and abraded skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of the same animal
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 8 days
- Number of animals:
- 3
- Details on study design:
- Application area: 2.5 x 2.5 cm
Application site: upper third of the back
After the end of the test substance application, the test substance was not washed off.
SCORING SYSTEM:
1) Erythema and Eschar Formation
a) No erythema = 0
b) Very slight erythema (barely perceptible) = 1
c) Well-defined erythema = 2
d) Moderate to severe erythema = 3
e) Severe erythema (beet redness) to slight eschar formation (injuries in depth) = 4
2) Edema formation
a) No edema = 0
b) Very slight edema (barely perceptible) = 1
c) Slight edema (edges of area well defined by definite raising) = 2
d) Moderate edema (raised approximately 1 mm) = 3
e) severe edema (raised more than 1 mm and extending beyond area of exposure) = 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- other: abraded skin
Applicant's summary and conclusion
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.
