Registration Dossier

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:
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:
1982
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

Constituent 1
Chemical structure
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
Constituent 2
Chemical structure
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

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.