Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 939-692-2 | CAS number: 1474044-73-9
Skin irritation / corrosion
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:
- 1 988
- 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
- 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
Constituent 1
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
