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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye 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:
1980-09-29 - 1980-10-06 (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
Guideline:
other: 16 CFR Section 1500.42
Version / remarks:
The methods employed in the testing, evaluation and in the grading of the test material are similar to those described in Section 1500.42 - Federal Hazardous Substances Act Regulation CFR 16 P. 125.
Deviations:
not specified
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium 1,3,4-thiadiazole-2,5-dithiolate
EC Number:
259-886-4
EC Name:
Disodium 1,3,4-thiadiazole-2,5-dithiolate
Cas Number:
55906-42-8
Molecular formula:
C2H2N2S3.2Na
IUPAC Name:
disodium 1,3,4-thiadiazole-2,5-dithiolate
Constituent 2
Chemical structure
Reference substance name:
Water
EC Number:
231-791-2
EC Name:
Water
Cas Number:
7732-18-5
Molecular formula:
H2O
IUPAC Name:
Water
Test material form:
liquid - solid: mixture of
Remarks:
water, Disodium 2,5-dimercapto-1,3,4-thiadiazole

Test animals / tissue source

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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
The first six rabbits did not have their eyes washed subsequent to instillation. The remaining three rabbits had the treated eyes washed after 30 seconds for 1 minute with tepid water (rate of flow approximately 1000 ml/minute).
Observation period (in vivo):
The treated eyes were examined at one, two, three, five, and seven days following instillation and washout of the test material into the eyes.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The first six rabbits did not have their eyes washed subsequent to instillation. The remaining three rabbits had the treated eyes washed after 30 seconds for 1 minute with tepid water (rate of flow approximately 1000 ml/minute).

SCORING SYSTEM: Interpretation of the results was made in accordance with the Draize Scale of Scoring Ocular Lesions.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity 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
Irritation parameter:
iris 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
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis 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
Irritant / corrosive response data:
Based on the accompanying tables, the subject material is not a primary ocular irritant within the definition of the Act-Reference: Section 1500.42 (b)(1)(2) and requires no cautionary labelling with respect to that section.
The material is not an ocular irritant in the unwashed eye. Washing does not appear to make a difference.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Study was performed scientifically reasonable similar to that described in Section 1500.42 ― Federal Hazardous Substances Act Regulations ― 16 CFR - P. 125 on a 30% aqueous solution of disodium 1,3,4-thiadiazole-2,5-dithiolate, and is sufficiently documented. Hence, the results can be considered as reliable to assess the irritating potential of disodium 1,3,4-thiadiazole-2,5-dithiolate on the rabbit eye in vivo.
In none of the animals in none of the scores, no indication of irritation was observed. Hence, it can be concluded that disodium 1,3,4-thiadiazole-2,5-dithiolate is not an eye irritant and does not need to be classified as such acc. Regulation 1272/2008.
Executive summary:

In a primary eye irritation study (16 CFR Section 1500.41), 0.1 ml of a 30% aqueous solution of disodium 1,3,4-thiadiazole-2,5-dithiolate was instilled into the conjunctival sac of the right eye of young albino rabbits. In six rabbits, the eye was not washed out, in 3 the eye was rinsed after 30 seconds. Animals then were observed for 21days.  Irritation was scored by the method of Draize.

In none of the animals in none of the scores, no indication of irritation was observed. Hence, it can be concluded that disodium 1,3,4-thiadiazole-2,5-dithiolate is not an eye irritant and does not need to be classified as such acc. Regulation 1272/2008.