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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions
Cross-reference
Reason / purpose:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
other company data
Title:
Unnamed
Year:
1966
Report Date:
1966
Reference Type:
secondary source
Title:
Unnamed
Year:
2000
Reference Type:
secondary source
Title:
SIDS Initial Assessment Report - 2-Methylbut-3-yn-ol
Author:
BASF AG
Year:
2002
Bibliographic source:
OECD SIDS

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:
Internal BASF method was used, which was in large part equivalent to methods described in OECD Guideline 404
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Analytical purity: 98.5%

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.9, 2.78 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: other side of same animal, treated with saline
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.2 ml
- Concentration (if solution): 100%
Duration of treatment / exposure:
1 min, 5 min, 15 min, 20 h
Observation period:
5 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm of back skin
- Type of wrap if used: cotton pad (seize: 2.5 cm x 2.5 cm) saturated with the undiluted test substance (ca. 0.5 ml)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): 50% Lutrol (polyethylenglycol) dilution in water
- Time after start of exposure: 1, 5, 15 min and 20 h


SCORING SYSTEM:
Erythema and edema were scored according the below described system:
Although the results in the report were originally not given as Draize scores the data can be transferred into the Draize scoring system (in brackets). (+) = none - negligible effect (0)
+ = slight effect (1)
++ = moderate effect (2)
+++ = severe effect (>= 3)
N = necrosis

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: after 20 h application
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: after 20 h application

Any other information on results incl. tables

Irritation scores acc. Draize::

Readings Animal Exposure period: 1 min Exposure period: 5 min Exposure period: 15 min Exposure period: 20 h
Erythema Edema Additional findings Erythema Edema Additional findings Erythema Edema Additional findings Erythema Edema Additional findings
1h 1 0 0   0 0   0 0   0 0  
2 0 0   0 0   0 0   0 0  
24 h 1 0 0   0 0   0 0   2 0 overlapping  test site
2 0 0   0 0   0 0   0 0  
48 h 1 0 0   0 0   0 0   0 0  
2 0 0   0 0   0 0   0 0  
72 h 1 0 0   0 0   0 0   0 0  
2 0 0   0 0   0 0   0 0  
96 h 1 0 0   0 0   0 0   0 0  
2 0 0   0 0   0 0   0 0  
Mean 24 - 72 h 1 0.0 0   0.0 0   0.0 0   0.7 0  
2 0.0 0   0.0 0   0.0 0   0.0 0  
Mean   0 0   0 0   0 0   0.3 0  

Applicant's summary and conclusion

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