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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
Study period:
17-20 Oct 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
Annex to Directive 92/69/EEC (OJ No. L383A, 29.12.92), Part B, Method B.4
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
Adopted 28 Jul 2015
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Good Laboratory Practice, The United Kingdom Compliance Programme, Department of Health & Social Security 1986 and subsequent revision, Department of Health 1989.

Test material

Constituent 1
Chemical structure
Reference substance name:
2,5-bis(1,1,3,3-tetramethylbutyl)hydroquinone
EC Number:
212-990-3
EC Name:
2,5-bis(1,1,3,3-tetramethylbutyl)hydroquinone
Cas Number:
903-19-5
Molecular formula:
C22H38O2
IUPAC Name:
2,5-bis(1,1,3,3-tetramethylbutyl)hydroquinone
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River UK Ltd., Margate, Kent, UK
- Age at study initiation: 13-15 wks
- Weight at study initiation: 3.0-3.5 kg (range)
- Housing: individually, in plastic cages with perforated floors
- Diet: SDS Stanrab (P) rabbit diet, ad libitum
- Water: drinking water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): ~19
- Humidity (%): 30-70
- Air changes (per hr): ~19
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 17 Oct 1995 To: 20 Oct 1995

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Remarks:
intact
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g
- Concentration: neat, as Sponsor supplied
Duration of treatment / exposure:
4 h
Reading time points: 1, 24, 48 and 72 h
Observation period:
Day 1 approximately 60 min after removal of the dressings, 24, 48 and 72 h after exposure ended.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: test substance was applied on the dorso-lumbar region under a 25 mm x 25 mm gauze pad moistened with 0.5 mL of distilled water.
- % coverage: not specified.
- Type of wrap if used: Elastoplast elastic adhesive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: with warm water (30 to 40°C)
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
- Day 1 approximately 60 min after removal of the dressings, then 24, 48 and 72 h after exposure to test substance ended.

SCORING SYSTEM:
- Method of calculation: numerical system ranking scores for both oedema and erythema at each evaluation (similar to Draize evaluation).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No numerical response to treatment was observed in any animal at any time throughout the observation period. The individual and mean erythema score at 24/48/72 h was 0.0 in 3 of 3 animals. The individual and mean edema score at 24/48/72 h was 0.0 in 3 of 3 animals.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008

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