Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988-03-15 - 1988-03-22
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well-documented OECD guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
5-[(2,2-dimethyldecyl)disulfanyl]-1,3,4-thiadiazole-2-thiol; bis[(2,2-dimethyldecyl)disulfanyl]-1,3,4-thiadiazole
EC Number:
939-692-2
Cas Number:
1474044-73-9
Molecular formula:
not applicable (UVCB substance)
IUPAC Name:
5-[(2,2-dimethyldecyl)disulfanyl]-1,3,4-thiadiazole-2-thiol; bis[(2,2-dimethyldecyl)disulfanyl]-1,3,4-thiadiazole
Test material form:
other: liquid
Details on test material:
- Physical state: light brown liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source/Breeder: Interfauna UK Ltd.
- Age: adult animals
- Sex: male
- Weight: 3.1 – 3.4 kg
- Animal Health was examined routinely, only healthy, symptom-free animals were used.
- Identification: by cage number and ear tattoo
- Housing: individually in wire cage type III – high, with a drawer for the faeces below filled with an absorbant, dust-free wood granulate type S 8/15 /Ssniff, Soest
- Diet: Standard diet “ssniff K 4” (Versuchstierdiäten GmbH, Soest/Westfalen), approx. 100-120 g/d and animal
- Water: Tap water, drinking water quality, ad libitum
-Acclimation period: at least 14 d

ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 2 °C
- Humidity (%): ca. 50 %
- Air changes: ca. 10/h
- Photoperiod (hrs dark / hrs light): 12 / 12
- Luminance intensity: ca. 27 Watt/m²

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated contralateral skin area served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500µL
Duration of treatment / exposure:
4 h
Observation period:
7 d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: flank, approx. 6cm²
- % coverage: semiocclusive
- Type of wrap if used: band-aid and elastic adhesive

REMOVAL OF TEST SUBSTANCE
- Washing: with water
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize (as set out in OECD 404)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: O49
Time point:
other: 1h, 24h, 48h, 72h, 7d
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal: N30
Time point:
other: 1h, 24h, 48h, 72h, 7d
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal: O14
Time point:
other: 1h, 24h, 48h, 72h, 7d
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal: O49
Time point:
other: 1h, 24h, 48h, 72h, 7d
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal: N30
Time point:
other: 1h, 24h, 48h, 72h, 7d
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal: O14
Time point:
other: 1h, 24h, 48h, 72h, 7d
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
No evidence of skin irritation and corrosion was noted during the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Criteria used for interpretation of results: EU-GHS
Conclusions:
The study was conducted according OECD Guideline 404 and is well-documented. Hence, the study can be considered as valid and the results as reliable. Consequently, the test item is considered as not irritating and not corrosive.
Executive summary:

In a dermal irritation study according to OECD Guideline 404 (Bayer AG, Märtins, 1988), 3 male adult albino-rabbits (strain: New Zealand White) were dermally exposed to 0.5 mL of the test item (1,3,4-Thiadiazolidine-2,5-dithione, reaction products with hydrogen peroxide and tert-dodecanethiol) for 4 hours to ca. 6cm² clipped skin. Afterwards, the exposed skin areas were washed with water and animals were observed for 7 days.

No erythema, eschar or oedema were observed at any time point.