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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 213-888-1 | CAS number: 1052-38-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study following official guideline in GLP
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4,4'-[1,3-phenylenebis(azo)]bisbenzene-1,3-diamine
- EC Number:
- 213-888-1
- EC Name:
- 4,4'-[1,3-phenylenebis(azo)]bisbenzene-1,3-diamine
- Cas Number:
- 1052-38-6
- Molecular formula:
- C18H18N8
- IUPAC Name:
- 4,4'-(1E,1'E)-1,3-phenylenebis(diazene-2,1-diyl)dibenzene-1,3-diamine
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: paste
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK Ltd, Wyton, Huntingdon, England
- Weight at study initiation: the animals were weighed immediately before application of the test substance
- Housing: the rabbits were individually housed in stainless steel cages with flat rod bases or polyethyelene cages with perforated bases. Excrement trays beneath the cages contained low-dust (wood) bedding . Bedding was regularly spotted for contaminants and changed at least twice weekly.All the animals were kept in one room
- Diet (e.g. ad libitum): standard diet "Saniff K4" approx. 100-120 g per animal/day, once per day in the morning
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: the animals were kept for at least 14 days in the quarantine station and monitored for diseases. During this period pooled faeces specimens were examined for coccidia oocysts
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 50%
- Air changes (per hr): apporx. 10 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours, artificial illumination from 6 to 18 hrs CET time
Test system
- Controls:
- other: the other eye remained untreated and served as control
- Amount / concentration applied:
- 100ul equivaletn to 90 mg
- Duration of treatment / exposure:
- 24h
- Observation period (in vivo):
- after rinsing with water the irritant effect was scored after 1,24,48,72h and 7,14,21d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): the eye was rinsed with saline
- Time after start of exposure: immediately after termination of 24h
SCORING SYSTEM: draize scoring system. The irritation indices/mean irritation indices were calculated for cornea, iris, erythema and swelling . Only effects persisting after 24h were included in the evaluation
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (draize score)
- Basis:
- other: mean of three animals
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Remarks:
- (draize score)
- Basis:
- other: mean of three animals
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Remarks:
- (driaze score)
- Basis:
- other: mean of three animals
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- other: discharge
- Basis:
- other: mean of three animals
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal:
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Other effects:
- any serious lesions or toxic effects were recorded: no effect
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified under Regulation 1272/2008
- Conclusions:
- The substance was tested for eye irritation following OECD 405. Under the test conditions the substance did not show irritating properties.
- Executive summary:
The substance was tested for eye irritation following OECD 405. The eyes of three New Zealand White rabbits were instilled with test item for 24h and then rinsed with saline solution. Irritating/corrosive effects in the cornea, iris and conjuncitvae (erythema,swelling and discherage) were checked and the mean calculated values at 24,48 and 72h for each animal resulted equal to zero. Under the experimental conditions the substance is not considered as eye irritant.
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.
