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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:
1996-10-29 to 1996-11-01
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study conducted without any deviation.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2-bis(hydroxymethyl)butanoic acid
EC Number:
424-090-1
EC Name:
2,2-bis(hydroxymethyl)butanoic acid
Cas Number:
10097-02-6
Molecular formula:
C6H12O4
IUPAC Name:
2,2-bis(hydroxymethyl)butanoic acid
Test material form:
other: solid
Details on test material:
- Name of test material (as cited in study report): DMBA
- Physical state: White solid
- Analytical purity: 99 %
- Lot/batch No.: 5J01
- Date of receipt: 1996-10-09
- Expiration date of the lot/batch: Six months from arrival
- Storage condition of test material: Room temperature in the dark

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, England.
- Age at study initiation: Approximately 12-15 weeks
- Weight at study initiation: 2.7-3.7 kg
- Housing: Animals were individually housed in metal cages with perforated floors.
- Diet: Standard laboratory diet SDS Stanrab (P) Rabbit Diet, ad libitum
- Water: Drinking water, ad libitum
- Acclimation period: NA

ENVIRONMENTAL CONDITIONS
- Temperature: 18-19 °C
- Humidity: 43-69 %
- Air changes: Approximately 19 air changes/hour
- Photoperiod: 12 hours dark / 12 hours light

IN-LIFE DATES: From: 1996-10-29 To: 1996-11-01

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: distilled water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of test material moistened with 0.5 ml of distilled water and applied.
Duration of treatment / exposure:
4 hours
Observation period:
Day 1 (i.e., approximately 60 minutes after removal the dressings) and on Days 2, 3 and 4 (equivalent to 24, 48 and 72 h after exposure).
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: Dorso-lumbar region; test item was applied under a 25 mm x 25 mm gauze pad which had been moistened with 0.5 mL distilled water to one intact skin site on each animal.
- Type of wrap if used: Treatment site was covered with "Elastoplast" elastic adhesive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: Treatment site was washed with warm water (30-40 °C) to remove any residual test substance and treated area was blotted dry with absorbent paper.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize method

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.22
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: No effects observed
Irritant / corrosive response data:
- Transient very slight erythema with or without very slight oedema was observed in all animals, resolving in all instances by Day 2 or Day 4.
Other effects:
- There were no signs of toxicity or ill health in any rabbit during the observation period.

Any other information on results incl. tables

Table 7.3.1/1: Results of skin irritation

Skin Reaction

Observation (Day)

Individual Scores – Rabbit Number and Sex (female)

764

765

766

Erythema

1*

1

1            

1

2

0

0

1

3

0

0

1

4

0

0

0

Mean (24, 48 and 72 h)

0.0

0.0

0.7

Oedema

1*

1

0

1

2

0

0

0

3

0

0

0

4

0

0

0

Mean (24, 48 and 72 h)

0.0

0.0

0.0

* Approximately 60 minutes after removal of the dressing; Days 2, 3 and 4 (equivalent to 24, 48 and 72 h after exposure).

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, DMBA is not classified as irritating to skin according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation (EC) N° (1272 -2008).
Executive summary:

Test Guidance

Performed according to EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion) guideline in compliance with GLP,

Method

Three New Zealand White female rabbits were dermally exposed to 0.5 g of DMBA (moistened with 0.5 mL distilled water) for 4 hours under a semi-occlusive dressing. After removal of the residual test item, irritation was scored according to Draize method at 1, 24, 48 and 72 hours after removal of dressings.

Results

There were no signs of toxicity or ill health in any rabbit during the observation period. Transient very slight erythema with or without very slight oedema was observed in all animals, resolving in all instances by Day 2 or Day 4. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0.0, 0.0, 0.7 for erythema and 0.0, 0.0, 0.0 for edema score, respectively. In this study, DMBA is not a skin irritant on rabbits.

Conclusion

Under the test conditions, DMBA is not classified as irritating to skin according to CLP Regulation (EC) N° (1272 -2008).

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