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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 943-498-3 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-10-02 to 1984-10-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Complete guideline conform study report available. Study is performed under GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction mass of methyl N-octadecylterephthalamate and 37437-26-6
- EC Number:
- 943-498-3
- Molecular formula:
- C27 H45 N O3 C44 H80 N2 O2
- IUPAC Name:
- Reaction mass of methyl N-octadecylterephthalamate and 37437-26-6
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- other: 0.9 % polyethyleneglycol
- Controls:
- not required
- Amount / concentration applied:
- 100 mg test substance moistened with 0.3 mL 0.9 % polyethyleneglycol
- Duration of treatment / exposure:
- 24 hours after application of the test substance into the conjuctival sac of the left eye, the eyes were washed out with lukewarm physiological saline.
- Observation period (in vivo):
- 1, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72 hrs
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72 hrs
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72 hurs
- Score:
- 0.1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hrs
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this test and the results obtained, it is concluded, that the test substance is not irritant to the eye.
- Executive summary:
In order to assess the eye irritating potential of the test substance, 100 mg of the test item moistened with 0.3 mL of 0.9 % polyethyleneglycol was applied into the conjunctival sac of the left eye of each of 3 rabbits. The untreated eye served as control. After 24 hours the treated eye was washed. The assessment of possible effects to the eyes was performed with the assistance of a lamp 60 minutes, 24, 48 and 72 hours after application of test item. The eye reactions were assessed according to the numerical scoring system (acc. to Draize). The description of the degree and nature of irritation and the presence of serious damage were noted as follows:
- No mortality or signs of systemic toxicity occurred.
- Hyperemia was observed in all three animals at the one hour and 24 hour time point with a maximum score of 2. This effect was still observed in one animal with a score of 1 at the 48 hour time point (mean score 0.7 - 1 - 0.3). This effect was reversible within 72 hours.
- Chemosis of the conjunctiva was observed in two animals one hour (maximal score 2) and in one animal 24 hours after application (mean score 0 - 0.3 - 0). This effect was reversible within 48 hours.
- No corneal opacity were observed in all three animals 24, 48 and 72 hours after application of the test substance (mean score 0-0-0).
- No effects at Iris was observed in all animals 24, 48 and 72 hours after application of the test substance (mean score 0-0-0).
Under the conditions of this test and the results obtained, it is concluded, that the test substance is not irritant to the eye.
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.
