[No public or meaningful name is available]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP compliant

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

4-Cyclohexan-1-ol, dodecyl-, branched

EC Number:

938-702-2

Molecular formula:

not applicable UVCB

IUPAC Name:

4-Cyclohexan-1-ol, dodecyl-, branched

Details on test material:

- Name of test material (as cited in study report): Cyclohexanol, 4-C11-12-alkyl, branched
- Substance type: pure active substance
- Physical state: liquid
- Storage condition of test material: room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, Germany
- Age at study initiation: approx. 22 - 23 weeks
- Weight at study initiation: 4.7 kg, 4.1 kg, 4.3 kg
- Housing: individually in ABS - plastic rabbit cages, floor 4200 cm²
- Diet: autoclaved hay and Altromin 2123 maintenance diet for rabbits ad libitum
- Water (e.g. ad libitum): tap water (drinking water, municipal residue control, microbiological controls at regulat intervals) ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12


IN-LIFE DATES: From: 2012-11-11 To: 2012-11-16

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

up to 72 hours after application

Number of animals or in vitro replicates:

3 (female)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done


SCORING SYSTEM: according to guideline


TOOL USED TO ASSESS SCORE: fluorescein solution at the end of the observation period

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

Animal no. 1 and 3 showed redness grade 1 and discharge grade 1 one hour p.a.. Animal no. 2 showed redness grade 1 and discharge grade 2 one hour p.a.. None of the test animals showed any signs of irritation at the 72 h reading. No corneal leasions were found upon fluorescein examination at the 72 h reading.

Other effects:

Neither mortalities nor significant clinical signs of toxicity were observed.

Any other information on results incl. tables

Table: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
60 min	0/0/0	0/0/0	1/1/1	0/0/0
24 h	0/0/0	0/0/0	1/1/1	0/0/0
48 h	0/0/0	0/0/0	1/1/1	0/0/0
72 h	0/0/0	0/0/0	0/0/0	0/0/0
Average 24h, 48h, 72h	0	0	0.67	0
Reversibility*)	-	-	c.	-
Average time (unit) for reversion	-	-	72 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:

The test item produced slightly irritant effects, which were fully reversible within 72 hours. No corrosion or irreversible effects were evident in any of the animals, neither mortalities nor significant clinical signs of toxicity were observed.

Executive summary:

An acute eye irritation/corrosion study with Cyclohexanol, 4 -C11 -12 -alkyl, branched were performed on rabbits according to OECD Guideline 405, adopted 24 April 2002. A single ocular application of the test item at a dose of 0.1 ml produced slightly irritant but no corrosive effects, which were fully reversible within 72 hours. Neither mortalities nor significant clinical signs of toxicity were observed. The eyes were not rinsed after application. Upon fluorescein examination at the end of the observation period of 72 hours no corneal lesions were found in any animal. Conjuctival redness grade 1 were observed in all animals up to 48 hours. Discharge were noted in all animals grade 1 or 2 one hour after application and in one animal grade 1 up 24 hours after application. The mean scores for the 24, 48 and 72 hours time points were as follows: Cornea = 0, Iris = 0, Conjuctival Redness= 0.67, Conjuctival Chemosis = 0.