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EC number: 214-780-7 | CAS number: 1193-81-3
- Life Cycle description
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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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- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
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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
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Reliability has been presented as 2 because a protocol similar to OECD Guideline has been followed but pre-GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- 1-cyclohexylethanol
- EC Number:
- 214-780-7
- EC Name:
- 1-cyclohexylethanol
- Cas Number:
- 1193-81-3
- Molecular formula:
- C8H16O
- IUPAC Name:
- 1-cyclohexylethanol
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- No further info on test animals and enivronmental conditions were provided.
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: animal #1
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: animal #2
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: animal #3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: animal #4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: animal #5
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: animal #6
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: animal #1
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: animal #2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: animal #3
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: animal #4
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: animal #5
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: animal #6
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness, similar to chemosis
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.83
- Max. score:
- 3.5
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: animal #1
- Remarks:
- No discrimination could be made between redness and chemosis.
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness, similar to chemosis
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.17
- Max. score:
- 3.5
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: animal #2
- Remarks:
- No discrimination could be made between redness and chemosis.
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness, similar to chemosis
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.83
- Max. score:
- 3.5
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: animal #3
- Remarks:
- No discrimination could be made between redness and chemosis.
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness, similar to chemosis
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3.5
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: animal #4
- Remarks:
- No discrimination could be made between redness and chemosis.
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness, similar to chemosis
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3.5
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: animal #5
- Remarks:
- No discrimination could be made between redness and chemosis.
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness, similar to chemosis
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3.5
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: animal #6
- Remarks:
- No discrimination could be made between redness and chemosis.
- Irritation parameter:
- chemosis score
- Remarks:
- chemosis, similar to redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.83
- Max. score:
- 3.5
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: animal #1
- Remarks:
- No discrimination could be made between redness and chemosis.
- Irritation parameter:
- chemosis score
- Remarks:
- chemosis, similar to redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.17
- Max. score:
- 3.5
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: animal #2
- Remarks:
- No discrimination could be made between redness and chemosis.
- Irritation parameter:
- chemosis score
- Remarks:
- chemosis, similar to redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.83
- Max. score:
- 3.5
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: animal #3
- Remarks:
- No discrimination could be made between redness and chemosis.
- Irritation parameter:
- chemosis score
- Remarks:
- chemosis, similar to redness
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3.5
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: animal #4
- Remarks:
- No discrimination could be made between redness and chemosis.
- Irritation parameter:
- chemosis score
- Remarks:
- chemosis, similar to redness
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3.5
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: animal #5
- Remarks:
- No discrimination could be made between redness and chemosis.
- Irritation parameter:
- chemosis score
- Remarks:
- chemosis, similar to redness
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3.5
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: animal #6
- Remarks:
- No discrimination could be made between redness and chemosis.
- Irritant / corrosive response data:
- For individual eye irritation scores as presented in the report, see table 1 in Any other information on results incl. tables.
Observations were as follows at different time points:
Immediate: slight discomfort
10 minutes: moderate erythema, copious discharge
1 hour: severe erythema, slight edema, copious discharge
24 hours: areas of barely percetible to slight corneal cloudiness, iris reaction to light was sluggish in three instances, slight to moderate erythema, very slight edema, copious discharge containing whitish exudate.
48-72 hours: gradual improvement
120 hours: all animals scored 0
FHSA method seems to make use of a modified Draize method. As in the report following is presented: mean score (x/110) and the maximum score in the Draize scoring system is also 110 it is assumed that this scoring system has been used. Though the scores used in the study are different from CLP criteria, the scores are recalculated resulting in the values presented in table 2, under Any other information on result incl. tables.
Any other information on results incl. tables
Tabel 1 Individual eye irritation scores
Animal No. |
1 hours |
24 hours |
48 hours |
72 hours |
120 hours |
168 hours |
||||||||||||
C |
I |
CJ |
C |
I |
CJ |
C |
I |
CJ |
C |
I |
CJ |
C |
I |
CJ |
C |
I |
CJ |
|
1 |
0 |
0 |
16 |
10 |
5 |
12 |
5 |
0 |
6 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
16 |
20 |
5 |
12 |
10 |
5 |
8 |
5 |
0 |
6 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
16 |
10 |
0 |
12 |
5 |
0 |
6 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
16 |
20 |
5 |
12 |
10 |
0 |
8 |
5 |
0 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
16 |
10 |
0 |
10 |
5 |
0 |
6 |
5 |
0 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
6 |
0 |
0 |
16 |
10 |
0 |
12 |
5 |
0 |
6 |
5 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
Mean |
16.0 |
27.5 |
14.1 |
7.3 |
0.0 |
0.0 |
C = Cornea
I = Iris
CJ = Conjunctivae
Table 2: Recalculated scores
Animal no. |
Cornea |
Cornea |
Cornea |
Cornea |
Iris |
Iris |
Iris |
Iris |
Conjunctiva |
Conjunctiva |
Conjunctiva |
Conjunctiva |
|
24h |
48h |
72h |
Average (24, 48, 72) |
24h |
48h |
72h |
Average (24, 48, 72) |
24h |
48h |
72h |
Average (24, 48, 72) |
1 |
2 |
1 |
0 |
1 |
1 |
0 |
0 |
0.33 |
3 |
1.5 |
1 |
1.83 |
2 |
4 |
2 |
1 |
2.33 |
1 |
1 |
0 |
0.67 |
3 |
2 |
1.5 |
2.17 |
3 |
2 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
3 |
1.5 |
1 |
1.83 |
4 |
4 |
2 |
1 |
2.33 |
1 |
0 |
0 |
0.33 |
3 |
2 |
1 |
2 |
5 |
2 |
1 |
1 |
1.33 |
0 |
0 |
0 |
0 |
2.5 |
1.5 |
1 |
1.67 |
6 |
2 |
1 |
1 |
1.33 |
0 |
0 |
0 |
0 |
3 |
1.5 |
0.5 |
1.67 |
Draize uses following caluclations:
Cornea = Opacity score x Area score x 5
Iris = Iris score x 5
Conjunctiva = (Redness score + Chemosis score + Discharge score) x 2
Based on the Draize calculations, cornea and iris values as presented in Table 1 are divided by 5 to recalculate the scores to be used under CLP. Conjunctiva scores are divided by 2 and though 3 effects are included in the Draize score (Redness, Chemosis and Discharge) the values are further divided by 2 considering two effects (Redness and Chemosis) and thus being conservative.
Applicant's summary and conclusion
- Interpretation of results:
- other: Eye irritant, Category 2
- Remarks:
- According to Regulation (EC) No 1272/2008 and its amendments.
- Conclusions:
- Based on the results of this study the test substance is considered to be an eye irritant.
- Executive summary:
The substance was tested in an eye irritation study equivalent to OECD TG 405. Six rabbits were exposed to the substance for 24 hours. Observations were made for 7 days. Mean irritation scores for cornea, iris and conjunctivae combined were 16.0, 27.5, 14.1 and 7.3 at respectively t=1, 24, 48 and 72 hours after application of the substance. This resulted in a mean overall irritation score (24, 48, 72 h) of 16.3. As the scores presented in the study are different form CLP criteria, the scores are recalculated per animal for cornea, iris and conjunctiva (average 24, 48 and 72h) resulting in the following scores: for cornea 1, 2.33, 1, 2.33, 1.33, and 1.33, for iris 0.33, 0.67, 0, 0.33, 0 and 0 and for conjunctiva 1.83, 2.17, 1.83, 2, 1.67 and 1.67 for animal 1, 2, 3, 4, 5 and 6 respectively. All adverse effects were fully reversed within 5 days. Based on these results, the substance is considered an eye irritant.
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