Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1968-09-24
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment; pre-GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report Date:
1968

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Before OECD Guideline 404 was established in 1984, skin irritation was tested using an internal method (BASF Test); the procedure of which is similar to OECD TG 404.
GLP compliance:
no
Remarks:
pre-GLP study

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 3-methyl-3-buten-1-ol
- Analytical purity: 99%
No further data

Test animals

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

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animals
Duration of treatment / exposure:
1, 5, and 15 minutes (short-term test);
20 hours (long-term test)
Number of animals:
2 (short-term test);
2 (long-term test):
totally 4 animals
Details on study design:
TEST SITE
- Area of exposure: back (short-term test and long term test); inner auricle (long-term test); see freetext

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water, possibly containing a mild detergent
- Time after start of exposure: at the end of the respective exposure period

SCORING SYSTEM:
BASF scoring system, convertible to Draize system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 8d
Score:
0
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
24-hour reading:
In one animal, questionable redness was observed at the dorsal skin that had been treated with the test substance for one minute; no signs of irritation were noted at the respective skin site of the other animal. Questionable and slight redness was observed at the dorsal areas treated for 5 minutes and longer in one animal each. Slight redness was noted at the auricular skin of both animals.

8-day reading:
No signs of irritation were observed at any skin site.

Any other information on results incl. tables

Table:  Skin findings and scores (converted to Draize system)

 

Application site

Exposure time

Findings at 24 h

Findings at 8 d

Animal no. 1

Animal no. 2

Animal no. 1

Animal no. 2

Back

1 min

5 min

15 min

Erythema: 0

Erythema: 1

Erythema: 1

No findings

Erythema: 0

Erythema: 0

No findings

at any treated

site

No findings

at any treated

site

Back

20 h

Erythema: 1

Erythema: 0

Ear

20 n

Erythema: 1

Erythema: 1

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The test substance was not a primary skin irritant under the conditions of this test.