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Toxicological information

Skin irritation / corrosion

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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:
1978
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

Constituent 1
Chemical structure
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

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