Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Remarks:
In vivo study performed prior (1980) to REACH implementation.
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1980-09-30 - 1980-10-03 (experimental phase)
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Given information allows the conclusion the study was well performed according to adopted guidelines, given data allows also conclusions on classification according to Regulation 1272/2008.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: CFR Section 1500.41
Version / remarks:
The method employed in the testing, evaluation and the scoring of the results was similar to that described in Section 1500.41 ― Federal Hazardous Substances Act Regulations ― 16 CFR - P. 124,
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: Albino
Details on test animals and environmental conditions:
TEST ANIMALS
- Housing: The animals were housed and maintained in compliance with the Animal Welfare Act (Pub. L-94-279) 9 CFR Part 3.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded and intact (clipped only)
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
Duration of treatment / exposure:
24h occlusive under Wrap. no wash-off
Observation period:
72h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: A 0.5 g portion of material was applied to an abraded and an intact skin site on the same rabbit.
- Type of wrap if used: Gauze patches were then placed over the treated areas and an impervious material was wrapped snugly around the trunks of the animals to hold the patches in place.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none washing stated

OBSERVATION TIME POINTS
after 24 and 72 hours

SCORING SYSTEM:
- Method of calculation: The Draize method of scoring was employed. Scoring of the results was similar to that described in Section 1500.41 ― Federal Hazardous Substances Act Regulations ― 16 CFR - P. 124.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24&72h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24&72h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24&72h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Remarks:
Information on the 48h timepoint not given, but as after 24h and 72h the score in each animal is zero, it can be concluded that this is the case also after 48h.
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Remarks:
Information on the 48h timepoint not given, but as after 24h and 72h the score in each animal is zero, it can be concluded that this is the case also after 48h.
Irritant / corrosive response data:
not irritant
Other effects:
- Other adverse local effects: none stated
- Other adverse systemic effects: none stated

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Study was performed scientifically reasonable similar to that described in Section 1500.41 ― Federal Hazardous Substances Act Regulations ― 16 CFR - P. 124 on 1,3,4-Thiadiazole-2,5-dithiole, and is sufficiently documented. Hence, the results can be considered as reliable to assess the irritating potential of 1,3,4-Thiadiazole-2,5-dithiole on intact and abraded rabbit skin. The primary irritation score was 0.00, none of the 6 rabbits showed any sign of irritation. Hence, the substance does not need to be classified as skin irritant acc. Regulation 1272/2008.
Executive summary:

In a primary dermal irritation study (16 CFR Section 1500.41), six Albino rabbits were dermally exposed to each 0.5 g of unchanged 1,3,4-Thiadiazole-2,5-dithiole for 24 hours to intact and abraded skin, no washing.  Animals then were observed for 3 days.  Irritation was scored by the method of Draize.

The primary irritation score was 0.00, none of the 6 rabbits showed any sign of irritation. The substance does not need to be classified as skin irritant acc. Regulation 1272/2008.