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: 204-881-4 | CAS number: 128-37-0
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:
- guideline study with acceptable restrictions
- Remarks:
- The dose level applied was 25 mg instead of 100 mg for solids, as recommended in the guideline. However, it is considered that this deviation does not affect the outcome of the study.
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
- Remarks:
- to
Reference
- Endpoint:
- eye irritation, other
- Remarks:
- read-across from supporting subtance
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read-across from an analogue substance for which a guideline study (Klimisch 2) is available.
- Reason / purpose for cross-reference:
- read-across source
- Principles of method if other than guideline:
- Read-across from company data on an analogue
- GLP compliance:
- yes
- Remarks on result:
- other: Read across, see cross reference to source information
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the rabbit eye irritancy test, the test material (source chemical) caused slight conjunctival redness within 1 hour of dosing which had cleared by 24 hours. The test material is therefore not an eye irritant in rabbits. The read across is applied and the target chemical BHT is considered to be non-irritant for the eyes.
- Executive summary:
The analogue CAS No. 118-82-1 (2,2',6,6'-tetra-tert-butyl-4,4'-methylenediphenol)which shares the same functional group (alkylphenol) with the substance CAS no. 128-37-0 (2,6-di-tert-butyl-p-cresol), also has comparable values for the relevant molecular properties. Therefore, the results obtained with the substance CAS No. 118-82-1 can be used for the read-across approach.
Based on company data, the read-across approach is applied from 2,2',6,6'-tetra-tert-butyl-4,4'-methylenediphenol and the substance 2,6 -di-tert-butyl-p-cresol (BHT) is considered to be non-irritant for the eyes.
The results are presented in the cross reference to the source information (read-across).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (However, it is considered that this deviation does not affect the outcome of the study).
- GLP compliance:
- yes
Test material
- Details on test material:
- - Physical state: Pale yellow powder
- Analytical purity: 99.04%
- Lot/batch No.: 5/87; Indent 9200/9622
- Storage condition of test material: Following its arrival in Compound Control this test substance was stored in the dark at ambient temperature.
- Stability: Infra-red spectra of the test substance were taken. There were no significant differences between the spectra and so, on this basis, the test substance was judged to have been stable for the duration of this study.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Sittingbourne Research Centre Breeding unit
- Age at study initiation: 4-9 months old
- Weight at study initiation: males: 3872-4184 g; females: 3276-4806 g
- Housing: Animals were singly housed in hanging, stainless-steel cages with all-mesh floors and tops and half-mesh fronts; each cage measured 67 cm x 43 cm x 45 cm.
- Diet (e.g. ad libitum): Standard Rabbit Diet, S.Q.C., Special Diet Services Ltd., Essex, ad libitum.
- Water (e.g. ad libitum): Filtered from the public supply , ad libitum.
- Acclimation period: At least, two weeks.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-19 ºC
- Humidity (%): Not documented.
- Air changes (per hr): Not documented.
- Photoperiod (hrs dark / hrs light): Lighting was automatically switched on for the day (06.00 to 18.00 hours GMT) and off for the night (18.00 to 06.00 hours GMT).
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg - Duration of treatment / exposure:
- The eyes were not washed.
- Observation period (in vivo):
- A visual assessment of eye irritancy was made at 1, 4, 24, 48 and 72 hours and 7 days after instillation.
- Number of animals or in vitro replicates:
- Three per sex
- Details on study design:
- SCORING SYSTEM: Irritancy was scored for the cornea, iris and conjunctivae using the standard scores included in the study report.
TOOL USED TO ASSESS SCORE: At 24 hours and in the event of any corneal damage visualization was aided by the instillation of one drop of 2% fluorescein solution.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 24 hours
- Remarks:
- The only occular effect was slight conjunctival redness in all rabbits within 1 hour of dosing.
- Irritant / corrosive response data:
- The instillation of the test substance powder into the conjunctival sac of one eye of each of six rabbits resulted in slight initial pain. The only occular effect was slight conjunctival redness in all rabbits within 1 hour of dosing which had cleared by 24 hours.
Any other information on results incl. tables
Table 7.3.2: Mean eye irritation scores
Redness | Chemosis | Discharge | Opacity | Iris | |
24 hours | 0 | 0 | 0 | 0 | 0 |
48 hours | 0 | 0 | 0 | 0 | 0 |
72 hours | 0 | 0 | 0 | 0 | 0 |
7 days | 0 | 0 | 0 | 0 | 0 |
Mean score 24-72 h | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the rabbit eye irritancy test, the test material caused slight conjunctival redness within 1 hour of dosing which had cleared by 24 hours. The test material is therefore not an eye irritant in rabbits.
- Executive summary:
The test material (25 mg) was applied to the eyes of six New Zealand White rabbits (3 per sex). A visual assessment of eye irritancy was made at 1, 4, 24, 48 and 72 hours and 7 days after instillation. The test material caused slight conjunctival redness within 1 hour of dosing which had cleared by 24 hours.
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.
Route: .live2