Registration Dossier
Registration Dossier
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EC number: 254-179-7 | CAS number: 38888-98-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1982-07-09 - 1982-08-05
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The non-GLP study was conducted according to an internationally accepted guideline. All study parameters are given in detail. According to the ECHA's practical guide 6: "How to report read-across and categories" the maximum for read-cross is 2.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: The experimental procedure used was based on that prescribed by the Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulations, Title 16, Section 1500.42.
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- SAS-296
- IUPAC Name:
- SAS-296
- Reference substance name:
- 4-(1-phenylethyl)-o-xylene
- EC Number:
- 228-249-2
- EC Name:
- 4-(1-phenylethyl)-o-xylene
- Cas Number:
- 6196-95-8
- Molecular formula:
- C16H18
- IUPAC Name:
- 1,2-dimethyl-4-(1-phenylethyl)benzene
- Reference substance name:
- 4-(1-phenylethyl)-m-xylene
- EC Number:
- 228-202-6
- EC Name:
- 4-(1-phenylethyl)-m-xylene
- Cas Number:
- 6165-52-2
- Molecular formula:
- C16H18
- IUPAC Name:
- 2,4-dimethyl-1-(1-phenylethyl)benzene
- Reference substance name:
- 2-(1-phenylethyl)-p-xylene
- EC Number:
- 228-201-0
- EC Name:
- 2-(1-phenylethyl)-p-xylene
- Cas Number:
- 6165-51-1
- Molecular formula:
- C16H18
- IUPAC Name:
- 1,4-dimethyl-2-(1-phenylethyl)benzene
- Test material form:
- other: liquid
- Details on test material:
- Description of test material: clear, colourless liquid
SAS-296 is a mixture of 3 isomeric structures.
Composition:
4-(1-phenylethyl)-o-xylene
4-(1-Phenylethyl)-m-xylene
2-(1-Phenylethyl)-p-xylene
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Six New Zealand White strain rabbits in the weight range 2.1 to 2.5 kg and approximately 9 to 11 weeks of age were obtained from Froxfield Rabbits, Petersfield, Hampshire.
The rabbits selected for the study were all suitably acclimatised to the laboratory environment.
Each animal was identified by a numbered aluminium tag placed through the edge of one ear. This number was unique within the HRC Industrial Toxicology Department throughout the duration of the study.
The rabbits were individually housed in metal cages with perforated floors. They had free access to tap water and laboratory animal diet Grain Harvester 474 Special Rabbit Pellets.
Animal room temperature was maintained at approximately 19°C and relative humidity at 30-70%.
Air exchange was maintained at approximately 19 air changes per hour and lighting was controlled by means of a time switch to give 12 hours of artificial light per day.
All animals were observed daily for signs of ill health or toxicosis.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- The eyes of each animal were examined prior to
instillation of the test substance to ensure that there was no pre-existing corneal damage or conjunctival inflammation.
A 0.1 ml aliquot of SAS-296 was placed into the lower everted lid of one eye of each animal.
The eyelids were then gently held together for one second before releasing. The contralateral eye remained untreated and served as a control.
Examination of the eyes was made 1, 2, 3, 4, and 7 days
after instillation. Observation of the eyes wa's aided by the use of a handheld torch.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 says
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: 1 animal only showed slight redness on days 1 and 2
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: No effects observed
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects observed
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 0
- Max. score:
- 13
- Reversibility:
- fully reversible within: 7 days
Any other information on results incl. tables
Rabbit Number and Sex |
Region of Eye |
Day after Instillation |
Results Positive(+)Negative(-) |
|||||
|
|
1 |
2 |
3 |
4 |
7 |
||
271 |
Cornea |
0 |
0 |
0 |
0 |
0 |
|
|
|
Iris |
0 |
0 |
0 |
0 |
0 |
|
|
|
Conjunctivae |
Redness |
0 |
0 |
0 |
0 |
0 |
- |
|
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
|
272 |
Cornea |
0 |
0 |
0 |
0 |
0 |
|
|
|
Iris |
0 |
0 |
0 |
0 |
0 |
|
|
|
Conj unctivae |
Redness |
0 |
0 |
0 |
0 |
0 |
- |
|
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
|
273 |
Cornea |
0 |
0 |
0 |
0 |
0 |
|
|
|
Iris |
0 |
0 |
0 |
0 |
0 |
|
|
|
Conjunctivae |
Redness |
0 |
0 |
0 |
0 |
0 |
- |
|
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
|
274 |
Cornea |
0 |
0 |
0 |
0 |
0 |
|
|
|
Iris |
0 |
0 |
0 |
0 |
0 |
|
|
|
Conjunctivae |
Redness |
1 |
1 |
0 |
0 |
0 |
- |
|
|
Chemosis |
1 |
0 |
0 |
0 |
0 |
|
275 |
Cornea |
0 |
0 |
0 |
0 |
0 |
|
|
|
Iris |
0 |
0 |
0 |
0 |
0 |
|
|
|
Conjunctivae |
Redness |
1 |
0 |
0 |
0 |
0 |
- |
|
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
|
276 |
Cornea |
0 |
0 |
0 |
0 |
0 |
|
|
|
Iris |
0 |
0 |
0 |
0 |
0 |
|
|
|
Conjunctivae |
Redness |
1 |
0 |
0 |
0 |
0 |
- |
|
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- SAS-296 was tested negative for eye irritation.
- Executive summary:
A study was performed in order to examine the eye irritation potential of SAS-296 to the rabbit eye mucosa. None of the animals gave a "positive" response. Transient mild conjunctival reactions were seen in three rabbits only. The eyes of two of these rabbits were normal by Day 2 and the eye of the third was normal by Day 3. No ocular reactions were observed in the remaining three animals during the observation period.
It is concluded that SAS-296 is not irritant to the rabbits eye.
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