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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:
1970
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
This study design follows OECD guideline 404 and extends requirements in certain details (e.g exposure time, number of animals, scarified skin, occlusive instead of semi-occlusive). The conduct and the findings of the study are well reported. However, some individual data were not included in the report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report date:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
increased exposure time, larger number of animals, scarified skin, occlusive instead of semi-occlusive conditions
GLP compliance:
no
Remarks:
performed before OECD GLP regulation became effective

Test material

Constituent 1
Chemical structure
Reference substance name:
1,3-dihydroxyacetone
EC Number:
202-494-5
EC Name:
1,3-dihydroxyacetone
Cas Number:
96-26-4
Molecular formula:
C3H6O3
IUPAC Name:
1,3-dihydroxyacetone

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Six male White New Zealand rabbits were used with either intact (3 animals) or scarified skin (3 animals).

TEST ANIMALS
- Source: E. Merck
- Age at study initiation: no information provided
- Weight at study initiation: mean 2,50 kg (2,32 - 2,80 kg)
- Housing: individual cages (Becker)
- Diet: Altromin, ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature, Humidity, Air changes, Photoperiod: no information provided

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
water
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g

VEHICLE
- Amount applied: low volume to moisten the test material

NEGATIVE CONTROL
- negative control: talcum, moistened with water
- Amount applied: 0.5 g

Duration of treatment / exposure:
24 h
Observation period:
7 d
Number of animals:
6 animals: 3 animals with intact skin (only shaved) and
3 animals with abraded skin (after shaving)
Details on study design:
TEST SITE
- Area of exposure: 4 cm2
- Type of wrap if used: occlusive

REMOVAL OF TEST SUBSTANCE
- Washing: removal of remaining test material with water 24 hours after start of exposure
- Time after start of exposure: 24 hours

OBSERVATION TIME POINTS
Once daily for 1 week

SCORING SYSTEM:
according to Draize /FDA (Appaisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics of the FDA, Baltimore MD, 1959)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0.83
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0.13
Max. score:
4
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: Scores are evaluated from the findings described in the report
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Directly after removal of the occlusive patches a slight reddening was observed in all rabbits both with intact or scarified skin up to day 2 (5 animals) or day 4 (one animal). Thereafter, all animals were without findings.
Other effects:
no

Any other information on results incl. tables

Skin reactions were evaluated and graded according to FDA appraisal. The scores were assessed from the description of effects provided in the report.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on this study the test material is considered to be not irritating to the skin.
Executive summary:

The skin irritation potential of the test material was investigated in six male White New Zealand rabbits following application either on intact (3 animals) or scarified skin (3 animals). Aliquots of neat test material (0.5 g) were moistened with water and applied to the intact or scarified skin of each rabbit for a 24-hour period under occlusive conditions. The rabbits were examined for skin reactions after removal of the patches daily for seven days. Skin reactions were evaluated and graded according to FDA appraisal. Directly after removal of the occlusive patches a slight reddening was observed in all rabbits both with intact or scarified skin up to day 2 (5 animals) or day 4 (one animal). Thereafter, all animals were without findings.

Based on this study the test material is considered not to be irritating to the skin.

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