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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable non-GLP study, comparable to guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not applicable
Qualifier:
equivalent or similar to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Before OECD Guideline 404 was first adopted in 1981, skin irritation was tested using a BASF test.
The methods were based on Draize (Federal Register 38, No. 187, § 1500.41, p. 27019 (1973-09-27)).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: Härter 421 flüssig; Äthanolaminhydrochlorid 45 % (German)
- Physical state: liquid

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
No data

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
5 minutes, 2 hours
20 hours
Observation period:
8 days
Number of animals:
2 rabbits (5 minutes, 2 hours)
6 rabbits (20 hours)
Details on study design:
TEST SITE
- Area of exposure: back (2.5 cm x 2.5 cm)

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 hours

SCORING SYSTEM
OECD Draize scores.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
(20-hour exposure)
Basis:
mean
Remarks:
(animal #1)
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: tested on intact skin
Irritation parameter:
erythema score
Remarks:
(20-hour exposure)
Basis:
mean
Remarks:
(animal #2)
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: tested on intact skin
Irritation parameter:
erythema score
Remarks:
(20-hour exposure)
Basis:
mean
Remarks:
(animal #3)
Time point:
other: 24/48/72 hours
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: tested on intact skin
Irritation parameter:
erythema score
Remarks:
(20-hour exposure)
Basis:
mean
Remarks:
(animal #4)
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: tested on intact skin
Irritation parameter:
erythema score
Remarks:
(20-hour exposure)
Basis:
mean
Remarks:
(animal #5)
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: tested on intact skin
Irritation parameter:
erythema score
Remarks:
(20-hour exposure)
Basis:
mean
Remarks:
(animal #6)
Time point:
other: 24/48/72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: tested on intact skin
Irritation parameter:
edema score
Remarks:
(20-hour exposure)
Basis:
mean
Remarks:
(animal #1)
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: tested on intact skin
Irritation parameter:
edema score
Remarks:
(20-hour exposure)
Basis:
mean
Remarks:
(animal #2)
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: tested on intact skin
Irritation parameter:
edema score
Remarks:
(20-hour exposure)
Basis:
mean
Remarks:
(animal #3)
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: tested on intact skin
Irritation parameter:
edema score
Remarks:
(20-hour exposure)
Basis:
mean
Remarks:
animal #4
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: tested on intact skin
Irritation parameter:
edema score
Remarks:
(20-hour exposure)
Basis:
mean
Remarks:
(animal #5)
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: tested on intact skin
Irritation parameter:
edema score
Remarks:
(20-hour exposure)
Basis:
mean
Remarks:
(animal #6)
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: tested on intact skin
Irritant / corrosive response data:
Test on intact skin, 20-hour application (key information):
The key results are summarised in the irritation/corrosion results table (see above).
The mean erythema score (24/48/72 hours) for the 6 rabbits ranged from 1 to 2. Findings were fully reversibe in 5/6 rabbits within 72 hours and in 1/6 rabbits within the observation period of 8 days.
The mean edema score (24/48/72 hours) for the 6 rabbits was 1. Findings were fully reversible within 72 hours.

Test on abraded (scarified) skin, 20- or 24-hour application (supporting information):
The mean erythema score (24/48/72 hours) for the 6 rabbits was 2.8. The erythema seen in all animals were not reversible within the 8-day observation period. On day 8, necroses indicative of strong irritancy were seen in 4/6 rabbits and scaling was noted in the 2 remaining rabbits.
The mean edema score (24/48/72 hours) for the 6 rabbits was 2.0. Edema were fully reversible in 5/6 rabbits within 8 days, while the edema score for the remaining rabbit was 2 on day 8.

Short-term test (supporting information):
No findings were noted in 2/2 rabbits (24/48 hours and 8 days) following exposure for 5 min. Exposure for 2 hours resulted in a mean erythema score of 0.5 (score 1 at 24 hours, score 0 at 48 hours) and no edema in both rabbits. The findings were fully reversible within 48 hours.
Other effects:
Macroscopic examination revelaed yellow discolouration of fat tissue in one rabbit and the presence of parasites in the liver of another rabbit. The local clinical findings noted during the in-life period (necrosis, scaling) were confirmed for all animals.

Any other information on results incl. tables

A primary irritation score of 3.53 was calculated (under consideration of the test results for intact plus abraded skin). The test substance was considered to be a moderate irritant based on this score.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU