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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1968-11-05 to 1968-11-13
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study predating guidelines and GLP, but scientifically fully acceptable.

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline followed
Deviations:
not applicable
Principles of method if other than guideline:
other: BASF test (close to Draize test), occlusive, 2 rabbits (+2 for 20h exposure and ear-skin test), intact skin; 1,5 or 15 minutes or 20h exposure
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methylbutan-2-ol
EC Number:
200-908-9
EC Name:
2-methylbutan-2-ol
Cas Number:
75-85-4
Molecular formula:
C5H12O
IUPAC Name:
2-methylbutan-2-ol

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.88 kg (male); 2.58 kg (male);
no body weight from additional two animals

ENVIRONMENTAL CONDITIONS
- no data

IN-LIFE DATES: From: 1968-11-05 To: 1968-11-13

Test system

Type of coverage:
occlusive
Preparation of test site:
other: exposure on back and ear
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
undiluted (2 mL / animal)
Duration of treatment / exposure:
1, 5 or 15 minutes
20 hours (20h data selected as worst case instead of non existing 4 h test)
Observation period:
The animals were observed 8 days.
Number of animals:
4 rabbits
Details on study design:
TEST SIDE
-Area of exposure: two rabbits at six sites per animal along the dorsum
Two additional rabbits: two sites per animal (plus left ear, not considered)
-% coverage: approximately 6 cm2 each

REMOVAL OF TEST SUBSTANCE
- Washing: yes, mild detergent (50% Lutrol)


SCORING SYSTEM: Draize score (converted from recorded grading with detailed instructions provided by data owner)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24h, 48h, 72h (mean)
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: Exposure duration 20h(instead of 4h, OECD 404)
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 h, 48h, 72h (mean)
Score:
0
Max. score:
4
Remarks on result:
other: Exposure duration 20h(instead of 4h, OECD 404)
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24h, 48h, 72h (mean)
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: Exposure duration 20h(instead of 4h, OECD 404)
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24h, 48h, 72h (mean)
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: Exposure duration 20h(instead of 4h, OECD 404)
Irritant / corrosive response data:
mean erythema / edema scores per animal below 2.3: not irritating

Applicant's summary and conclusion

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