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EC number: 203-253-7 | CAS number: 104-93-8
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- Terrestrial toxicity
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

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:
- other: Guideline study with acceptable restrictions, i.e. limited observation period.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- 4-methylanisole
- EC Number:
- 203-253-7
- EC Name:
- 4-methylanisole
- Cas Number:
- 104-93-8
- Molecular formula:
- C8H10O
- IUPAC Name:
- 1-methoxy-4-methylbenzene
- Details on test material:
- - Name of test material (as cited in study report): p-Methylanisol
- Analytical purity: > 99.5 %
- Lot/batch No.: P 16
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Savo; Med. Versuchstierzuchten GmbH, Kisslegg, Germany
- Mean weight at study initiation: males 3.09 kg, female 2.95 kg
- Housing: individually in stainless steel cages with wire mesh walk floors (40 cm x 51 cm)
- Diet: Kliba 341, 4 mm (Klingentalmühle AG, Kaiseraugst, Switzerland), ca. 130 g per day
- Water: ca. 250 ml tap water per animal per day
- Acclimation period: at least 8 days before the beginning of the study; same housing conditions as during the study
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Humidity: 30 - 70 %
- Air changes: fully air-conditioned rooms
- Photoperiod: 12 hrs dark / 12 hrs light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye of the same animal served as control
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml - Duration of treatment / exposure:
- the substance was not washed out
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 (2 males and 1 female)
- Details on study design:
- 0.1 ml of the test material was applied into the conjunctival sac of the animals. The substance was not washed out.
Reading time points were 1 h, 24 h, 48 h and 72 h after application of the test material.
The scores were calculated according to the method of Draize.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24-48-72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24-48-72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24-48-72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24-48-72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24-48-72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
Any other information on results incl. tables
Table 1: Scores for eye irritation of the individual animals at different reading time points:
reading |
animal |
cornea |
iris |
conjunctiva redness |
conjunctiva chemosis |
symptoms |
1 hour |
1 |
0 |
0 |
2 |
0 |
|
2 |
0 |
0 |
2 |
1 |
|
|
3 |
0 |
0 |
2 |
1 |
|
|
24 h |
1 |
0 |
0 |
1 |
0 |
|
2 |
1 |
1 |
2 |
1 |
pupil contracted; small retractions in the eyelids |
|
3 |
0 |
0 |
1 |
0 |
pupil contracted |
|
48 h |
1 |
0 |
0 |
1 |
0 |
|
2 |
0 |
0 |
1 |
0 |
pupil contracted; small retractions in the eyelids |
|
3 |
0 |
0 |
1 |
0 |
pupil contracted |
|
72 h |
1 |
0 |
0 |
0 |
0 |
|
2 |
0 |
0 |
0 |
0 |
pupil contracted |
|
3 |
0 |
0 |
0 |
0 |
pupil contracted |
Applicant's summary and conclusion
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.
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