Reaction mass of 2-octyldodecyl 2-hydroxypropanoate, 2-Octyldodecan-1-ol and 2-octyldodecyl 2-[(2-hydroxypropanoyl)oxy]propanoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 16, 2001 - November 16th, 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

The protocol is designed to satisfy the requirements of the Japanese Ministry of Health and Welfare.
The procedure is a modification of that descrbed by J. H. Draize.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Cosmol 13

IUPAC Name:

Cosmol 13

Specific details on test material used for the study:

Lot No. 1-8-A

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: about 3 month
- Weight at study initiation: about 2 kg
- Housing: stainless steel cages
- Diet (e.g. ad libitum): 100 g/d
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18° - 24 °C
- Humidity (%): no data
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml of test article, used as received

Duration of treatment / exposure:

ammount applied was rinsed after 24 hours if still present

Observation period (in vivo):

7 days, with controls at 1, 24, 48 and 72 h and on day 4 and 7 if irritation was observed at 72 h.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with distilled water
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize's scoring system applied

TOOL USED TO ASSESS SCORE: no data

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 7

Irritation parameter:

other: Conjunctivae discharge

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of theis test, Cosmol 13 elicited minimal to mild, transient, conjunctival redness and minimal, transient edema to the eyes of rabbits. The Draize score is 4.7 of 110 and therefor the substance can be characterised as minimally irritating.