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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. Lack of details on test material (analytical purity).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
lack of details on test material (analytical purity)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): methyl cyclohexane
- Substance type: technical product
- Physical state: liquid
- Analytical purity: no data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Laboratory Animals, Inc.
- Age at study initiation: adult
- Housing: individual
- Diet: Purina Lab Rabbit Chow®, ad libitum. Feed was periodically analyzed for concentrations of specified heavy metals, antibiotics, aflatoxin, pesticides, and nitrosamines
- Water: Tap water, ad libitum. The water was routinely analyzed on a retrospective basis for specified microorganisms, pesticides, heavy metals, alkalinity, and halogens.
- Quarantine: Minimum of 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 40-60
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Single instillation without washing
Observation period (in vivo):
7 days
Reading time points: 1, 24, 48, and 72 h, and at 4 and 7 days
Number of animals or in vitro replicates:
3 males and 3 females
Details on study design:
SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of animals #1-3 and #5, #6
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: mean over 24, 48 and 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
over all 6 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
1 h post-instillation: conjuctival redness (vessels injected above normal) was noted in 4/6 rabbits as only eye effect.
24 h post-instillation: conjuctival redness (vessels injected above normal) was noted in 1/6 rabbits as only eye effect.
48 h to 7 days: No corneal opacity, iritis, conjunctival redness, chemosis or discharge were observed.
Other effects:
No further local or systemic effects were reported.

Any other information on results incl. tables

Table 1: Evaluation of the eye reaction

Rabbit No. / sex

Scoring [h]

Cornea

Iris

Conjunctiva

Redness

Chemosis

#1 / m

1

0

0

0

0

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

Mean (24, 48, 72 h)

0

0

0

0

 

#2 / m

1

0

0

1

0

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

Mean (24, 48, 72 h)

0

0

0

0

 

#3 / m

1

0

0

1

0

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

Mean (24, 48, 72 h)

0

0

0

0

 

#4 / f

1

0

0

1

0

24

0

0

1

0

48

0

0

0

0

72

0

0

0

0

Mean (24, 48, 72 h)

0

0

0.33

0

 

#5 / f

1

0

0

0

0

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

Mean (24, 48, 72 h)

0

0

0

0

 

#6 / f

1

0

0

1

0

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

Mean (24, 48, 72 h)

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:
Methylcyclohexane was tested for primary eye irritation in 3 male and 3 female rabbits in a study following a protocol similar to OECD guideline 405. The test material (0.1 mL) was applied into the conjunctival sac of one eye, the other eye serving as control. The eyes were examined and scored 1, 24, 48 and 72 h as well as 4 and 7 days after application. No corneal opacity, iritis or chemosis were observed in any animal at any reading time point (all scores 0.0). Slight conjunctival redness was seen in 4/6 rabbits 1 h post-application, which persisted in only 1/6 animals at the 24 h reading. No conjunctival redness was observed at the following scoring time points. The mean conjunctivae score over 24, 48 and 72 h was 0.3 for this animal and 0.0 for the remaining 5 animals.

In this study, no corneal opacity, iritis or chemosis and only slight and transient conjunctival redness were observed in rabbit eyes treated with methylcyclohexane; the effects being fully reversible within 24-48 h post-instillation. Therefore, the study results do not fulfil the classification criteria for eye irritation according to Regulation (EC) 1272/2008 and Directive 67/548/EEC.

CLP: not classified
DSD: not classified