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
Eye irritation
Administrative data
- Endpoint:
- eye 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 without deviations on ‘1,3,4-Thiadiazolidine-2,5-dithione, reaction products with hydrogen peroxide and tert-dodecanethiol’.
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 405 (Acute Eye 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues 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
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated eye served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100µL - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 7 d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- APPLICATION OF TEST SUBSTANCE
100µL of the test item were applied in the conjunctival sac of one eye. The second eye remains untreated as control.
REMOVAL OF TEST SUBSTANCE
- Washing: physiological NaCl-solution
- Time after start of exposure: 24h
SCORING SYSTEM: Draize (as set in OECD Guideline 405)
TOOL USED TO ASSESS SCORE: optical aids / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: cornea opacity
- Basis:
- mean
- Time point:
- other: 1h, 24h, 48h, 72h, 7d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- other: cornea area
- Basis:
- mean
- Time point:
- other: 1h, 24h, 48h, 72h, 7d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1h, 24h, 48h, 72h, 7d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- other: conjunctivae redness
- Basis:
- mean
- Time point:
- other: 1h, 24h, 48h, 72h, 7d
- Score:
- 0.2
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- other: conjunctivae swelling
- Basis:
- mean
- Time point:
- other: 1h, 24h, 48h, 72h, 7d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- other: conjunctivae lacrimation
- Basis:
- mean
- Time point:
- other: 1 h, 24h, 48h, 72h, 7d
- Score:
- 0.2
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1h, 24h, 48h, 72h, 7d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1h, 24h, 48h, 72h, 7d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1h, 24h, 48h, 72h, 7d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Under the conditions of this test, the test item was considered to be non-irritating to the eye.
Any other information on results incl. tables
Table 1. Raw data
Animal No. |
Observed Endpoint |
Draize-Scoring |
Mean |
||||
1h |
24h |
48h |
72h |
7d |
|||
O39 ♂ (3.5kg) |
Cornea opacity |
0 |
0 |
0 |
0 |
0 |
0.0 |
Cornea area |
0 |
0 |
0 |
0 |
0 |
||
Iris |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
Conjunctivae redness |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
Conjunctivae swelling |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
Conjunctivae lacrimation |
0 |
0 |
0 |
0 |
0 |
|
|
Fluorescein |
--- |
n |
--- |
--- |
--- |
|
|
O44 ♂ (3.1kg) |
Cornea opacity |
0 |
0 |
0 |
0 |
0 |
0.0 |
Cornea area |
0 |
0 |
0 |
0 |
0 |
||
Iris |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
Conjunctivae redness |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
Conjunctivae swelling |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
Conjunctivae lacrimation |
0 |
0 |
0 |
0 |
0 |
|
|
Fluorescein |
--- |
n |
--- |
--- |
--- |
|
|
N63 ♂ (3.1kg) |
Cornea opacity |
0 |
0 |
0 |
0 |
0 |
0.0 |
Cornea area |
0 |
0 |
0 |
0 |
0 |
||
Iris |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
Conjunctivae redness |
1 |
0 |
0 |
0 |
0 |
0.2 |
|
Conjunctivae swelling |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
Conjunctivae lacrimation |
1 |
0 |
0 |
0 |
0 |
0.2 |
|
Fluorescein |
--- |
n |
--- |
--- |
--- |
|
|
--- = not examined; n = negative
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 to OECD Guideline 405 and is well-documented. Hence, the study can be considered as valid and the results as reliable (Klimisch 2). Consequently, the test item is considered as not irritating to the eye.
- Executive summary:
In an eye irritation study according to OECD Guideline 405 (Bayer AG, Märtins, 1988), 100 µL of the test item (1,3,4-Thiadiazolidine-2,5-dithione, reaction products with hydrogen peroxide and tert-dodecanethiol) was instilled into the conjunctival sac of one eye of each 3 male adult albino rabbits (strain: New Zealand White) for 24 hours. The untreated eye served as control. After the exposure period, the treated eye was washed with physiological saline. The animals were then observed for 7 days. Irritation was scored according to the method of Draize. Except a slight, fully reversible conjunctivae redness and lacrimation 1 h after exposure in one animal, no other effects were observed.
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.
