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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 226-364-2 | CAS number: 5372-81-6
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: well performed GLP and OECD guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dimethyl 2-aminoterephthalate
- EC Number:
- 226-364-2
- EC Name:
- Dimethyl 2-aminoterephthalate
- Cas Number:
- 5372-81-6
- Molecular formula:
- C10H11NO4
- IUPAC Name:
- 1,4-dimethyl 2-aminobenzene-1,4-dicarboxylate
- Reference substance name:
- Dimethyl-2-Aminoterephthalate
- IUPAC Name:
- Dimethyl-2-Aminoterephthalate
- Details on test material:
- - Name of test material (as cited in study report): Aminoterephthalsäuredimethylester
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Chemical pharmaceutical factory Or. K. Thomae
- Age at study initiation: about 3 - 5 months
- Weight at study initiation: 3.4 - 3.9 kg
- Housing: in fully air-conditioned rooms, separate cages
- Diet (e.g. ad libitum): Altromin 2123 maintenance diet - rabbits, ad libitum
- Water (e.g. ad libitum): water from automatic water dispensers, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ±20
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated eyes served in each case as a control.
- Amount / concentration applied:
- 100 mg of the undiluted test substance
- Duration of treatment / exposure:
- 24 hours after application eyes were washed out thoroughly with isotonic saline at approx. 37 °C.
- Observation period (in vivo):
- The eyes were examined 1, 24, 48 and 72 hours after application of the test item
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: # 171, 172, 189 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of irritation (cornea) at any time
- Irritation parameter:
- iris score
- Basis:
- animal: # 171, 172, 189 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no signs of irritation (iris) at any time
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 171, 189 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: initial slight effects (redness) were fully reversible within 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 172
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: # 171, 172, 189 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of irritation (chemosis) at any time
- Irritant / corrosive response data:
- From one hour up to 24 hours p.a. the conjunctivae of the animals showed definitely injected blood vessels to more diffuse, deeper crimson reddenings. A clear, colourless discharge was observed in one animal. 48 hours p.a. the irritations were reversible.
- Other effects:
- No other effects reported
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Based on the findings in this test the test substance is not eye-irritating.
- Executive summary:
Aminoterephthalsäuredimethylester was tested for eye irritating properties according to OECD 405. Following this protocol 100 mg of the undiluted test substance were applied into the conjunctival sac of one eye from each of three rabbits. The other eye remained untreated and served as control. After 24 h exposure time the eyes were rinsed with physiol. saline. The eyes of the animals were examined at 1, 24, 48, 72 h, after the test substance application. Mean scores (mean of 24, 48, 72 h) were calculated for cornea, iris, conjunctivae redness, and conjunctivae chemosis in each animal.
Based on the findings in this test the test substance is not eye-irritating.
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.
