Fatty acids, tall-oil, reaction products with triethanolamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted according to internationally accepted technical guideline and in compliance with GLP in recognized contract research organization. Despite some minor restrictions, the study report is fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

of 1981

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Certified by BAM according to DIN EN 45001.

Test material

Test material information

Constituent 1

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

- Number: 3 animals,
- Average bodyweight: 3.2 kg
- Housing: Individual housing in cages.
- Diet: Commercially available standard laboratory diet for rabbits ( Altromin, Lage, Germany).
- Water: Ad libitum

ENVIRONMENTAL CONDITIONS

Room temperature kept constant at 18±2°C, the relative humidity at 50-60%. 12 hours illumination per day.

Test system

Vehicle:

other: undiluted (no vehicle) after warming the test material to 37°C

Controls:

not required

Amount / concentration applied:

After warming undiluted test material (no vehicle) to 37°C, 0.1 ml of it was administered into the conjunctival sac of one eye per rabbit. The contralateral eye remained untreated to serve as a control.

Duration of treatment / exposure:

There was no mentioning in the report that eyes were rinsed after treatment. Consequently the treatment/exposure period was equivalent to the entire observation period following administration, which was 7 days, or lasted until removal of the test material by physiological mechanisms, whichever happened sooner.

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3 adult rabbits

Details on study design:

There was no mentioning in the report that eyes were rinsed after administration of the test material.

Eyes were evaluated for occular lesions using ultraviolet light. The numerical scoring system listed in Table 1 in the field below was adopted. Time points of evaluation were: Pretest (prior to treatment), 1, 2, 4, 8, 24, 48, 72 and 96 hours after administration and daily thereafter until 7 days after administration. Grades attained at 24, 48 and 72 hours after administration were included in the mean gradings of ocular lesions used for eye irritation/corrosion classification.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

over 3 animals and 3 time points

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: Corneal irritation or opacity was not evident during the study

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

over 3 animals and 3 time points

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

2

Reversibility:

other: Iridal changes were not evident during the study

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Remarks:

over 3 animals and 3 time points

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 24 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

over 3 animals and 3 time points

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: Chemosis was not evident during the study

Results 5

Irritation parameter:

other: lacrimation score

Basis:

mean

Remarks:

over 3 animals and 3 time points

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 24 hours

Irritant / corrosive response data:

Corneal and iridic lesions and chemosis were not evident throughout the study. Conjunctival redness and lacrimation, both findings grade 1, were seen in all treated eyes at 1, 2, 4 and/or 8 hours post dosing. Conjunctival redness had completely disappeared in one of the animals by 8 hours post dosing and in the other two by 24 hours post dosing and lacrimation had completely disappeared in two of the animals by 8 hours post dosing and in the other one by 24 hours post dosing. Daily examination of the eyes from 24 hours until 7 days post dosing did not reveal any findings.

Other effects:

Daily determination of bodyweight did not reveal any test related changes. Bodyweight gain was normal.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU