Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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: 202-506-9 | CAS number: 96-45-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions. Restriction : no data on purity, no quantitative data for ETU
Data source
Reference
- Reference Type:
- publication
- Title:
- Studies on eye irritation caused by chemicals in rabbits - 1.A quantitative structure-activity relationships approach to primary eye irritation of chemicals in rabbits.
- Author:
- Sugai S, Murata K, Kitagaki T, and Tomita I.
- Year:
- 1 990
- Bibliographic source:
- The Journal of Toxicological Sciences, Vol. 15, 245-262.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no score are available.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Imidazolidine-2-thione
- EC Number:
- 202-506-9
- EC Name:
- Imidazolidine-2-thione
- Cas Number:
- 96-45-7
- Molecular formula:
- C3H6N2S
- IUPAC Name:
- imidazolidine-2-thione
- Details on test material:
- Other name = Ethylenethiourea (ETU)
ETU was purchased from Wako Pure Chemical Industry (Osaka, Japon), Aldrich Chemical Company (Winsconsin, USA), Dojindo Laboratories (Kumamoto, Japan) orTokyo Kasei Kogyo Co. (Tokyo Japan).
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Japanese white (females)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Shizuoka, Japan
- Age at study initiation: no data
- Weight at study initiation: 2.0-2.2 kg
- Housing: in metal cages (39 x40x44 cm)
- Diet (e.g. ad libitum): RC4 diet (Oriental Yeast Co., Tokyo Japan), ad libitum
- Water (e.g. ad libitum): not precised, ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25 +/-1°C
- Humidity (%): 55+/-5%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- not specified
- Controls:
- yes
- Amount / concentration applied:
- The chemical (Solid = 100 mg ; liquid = 0.1 ml) was placed into conjunctival sac of the left eye.
The right eye was served as a blank. - Duration of treatment / exposure:
- 1 single administration
- Observation period (in vivo):
- 1, 4, 24, 48, 72, 96 hr, and 7, 14, 21 days after the treatment of chemical.
- Number of animals or in vitro replicates:
- 3 animals/ group
- Details on study design:
- REMOVAL OF TEST SUBSTANCE : no data
SCORING SYSTEM: Corneal opacity, erythema, chemosis, secreta and iritis were classified according to the Draize score (1944).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Remarks:
- Draize score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- <= 7
- Max. score:
- 110
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: Minimal irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: data not reported
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: data not reported
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: data not reported
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: data not reported
- Irritant / corrosive response data:
- There was no quantitative data for ETU.
It was a chemical which inducing no or mild damage recovering within 24 hr. This score distributed from 0 up to 7.0 . - Other effects:
- no
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- ETU was in class I, it was a non or mild irritant.
- Executive summary:
The Draize eye irritation test has been used as an attempt to predict ocular irritancy of chemicals.The eye irritation ratings were made in three classes on the basis of the recovery time of corneal and conjunctival damages. A three-class discrimination was made as follows; class I included chemicals which induced the damages recovering within 24 hr, class II included chemicals which induced the damages persisting for more than 24 hr but recovering within 21 days, class III included chemicals which induced the damages not recovering within 21 days. ETU was a non or mild irritant (class 1).
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.
