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EC number: 250-954-9 | CAS number: 32210-23-4
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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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
- Study period:
- From 1982-01-14 to 1982-01-26
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Comparable to guideline study with acceptable restrictions: the study is non-GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: USA IRLG Testing Standards and Guidelines Work Group (January 1981)
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
Test material
- Reference substance name:
- trans-4-tert-butylcyclohexyl acetate
- EC Number:
- 217-598-6
- EC Name:
- trans-4-tert-butylcyclohexyl acetate
- Cas Number:
- 1900-69-2
- Molecular formula:
- C12H22O2
- IUPAC Name:
- trans-4-tert-butylcyclohexyl acetate
- Reference substance name:
- cis-4-tert-butylcyclohexyl acetate
- EC Number:
- 233-881-7
- EC Name:
- cis-4-tert-butylcyclohexyl acetate
- Cas Number:
- 10411-92-4
- Molecular formula:
- C12H22O2
- IUPAC Name:
- cis-4-tert-butylcyclohexyl acetate
- Test material form:
- liquid
- Details on test material:
- - Description: colourless liquid
- Storage conditions: in the dark at room temperature
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: H. Fortkamp, 4540 Lengerich.
- Age at study initiation: 11-17 weeks
- Weight at study initiation: 2.20-2.63 kg bw
- Housing: individually, in steel greed floor cages over trays containing softwood sawdust bedding.
- Diet: ad libitum (Ssniff K Alleindiät für Kanichen, Ssniff Versuchstier-GmbH, 4770 Soest/Westfalen). Not contaminated.
- Water: main water ad libitum. Not contaminated.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 40-70
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: right eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Eye were not rinsed after instillation
- Observation period (in vivo):
- Examination 1, 24, 48, 72 hours, and then 4 and 7 days after instillation
- Number of animals or in vitro replicates:
- 6 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no done
SCORING SYSTEM: Draize scale
TOOL USED TO ASSESS SCORE: no data
Other: initial pain reaction caused by the test article was made using a 6 point scale.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.04
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.17
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.04
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritant / corrosive response data:
- Practically no initial pain was seen in any animal on instillation. One hour after dosing moderate chemosis (grade 2) associated with moderate reddening (grade 2) were observed in 2/6 animals. The remaining 4 animals all showed slight chemosis (grade 1) and slight reddening (grade 1). The day after dosing one animal still showed slight chemosis associated with moderate reddening an on this occasion diffuse areas of corneal opacity and a slight ocular discharge were also noted. One further animal showed slight reddening only whilst the eyes of the remaining 4 animals appeared normal. Two days after treatment the eyes of all animals appeared normal.
- Other effects:
- None
Any other information on results incl. tables
Table 7.3.2/1: Mean irritant/corrosive response data for all animals at each observation time up to removal from the test
Score at time point / Reversibility |
Cornea |
Iris (/2) |
Conjunctivae |
|||
Opacity (/4) |
Area (/4) |
Redness (/3) |
Chemosis (/4) |
Discharge (/3) |
||
1 h |
0.00 |
0.00 |
0.00 |
1.33 |
1.33 |
0.00 |
24 h |
0.13 |
0.25 |
0.00 |
0.50 |
0.13 |
0.00 |
48 h |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
72 h |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
Average 24h, 48h, 72h |
0.04 |
0.08 |
0.00 |
0.17 |
0.04 |
0.00 |
Reversibility*) |
c. |
c. |
- |
c. |
c. |
- |
Average time (unit) for reversion |
48h |
48h |
- |
48 h |
48 h |
- |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test material is not classified as irritating to eyes according to the criteria of the Regulation (EC) No 1272/2008 (CLP) and of the GHS
- Executive summary:
In an eye irritation study performed similarly to the OECD guideline No. 405, 0.1 mL of undiluted test material was instilled into the left eye of 6 female New Zealand White Rabbit. The eyes were not rinsed after the instillation of the test item. The right eye of each rabbit served as control. Animals were observed at 1, 24, 48 and 72 hours, and the 4 and 7 days after dosing. The reactions in the conjunctiva (redness, chemosis and discharge), the iris and the cornea (opacity and area involved) were scored according to the Draize scale.
Practically no initial pain was seen in any animal on instillation. One hour after dosing moderate chemosis (grade 2) associated with moderate reddening (grade 2) were observed in 2/6 animals. The remaining 4 animals all showed slight chemosis (grade 1) and slight reddening (grade 1). The day after dosing one animal still showed slight chemosis associated with moderate reddening an on this occasion diffuse areas of corneal opacity and a slight ocular discharge were also noted. One further animal showed slight reddening only whilst the eyes of the remaining 4 animals appeared normal. 48 hours after treatment the eyes of all animals appeared normal.
The calculated mean score for each individual lesion for all 6 animals within 3 scoring times (24, 48 and 72 hrs) were as follows: 0.17 for redness, 0.04 for chemosis; 0.08 for cornea opacity; 0.04 for area of cornea involved and 0.00 for discharge, iris and lesions.
Under the test conditions, the test material is not classified as irritating to eyes according to the criteria of the Regulation (EC) No 1272/2008 (CLP) and of the GHS.
This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
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