Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From January 23, 1990 to February 14, 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to OECD 405 guideline study, but not in compliance with GLP.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

68425-47-8

Cas Number:

68425-47-8

IUPAC Name:

68425-47-8

Constituent 2

Reference substance name:

Amides, soya, N,N-bis(hydroxyethyl)

EC Number:

270-355-6

EC Name:

Amides, soya, N,N-bis(hydroxyethyl)

IUPAC Name:

270-355-6

Test material form:

other: Yellow liquid

Details on test material:

- Name of test material (as cited in study report): Marlamid DF 1818
- Physical state: Yellow liquid
- Composition of test material, percentage of components:
80% soybean oil diethanolamide, 10% glycerin, 5% diethanolamide salt of the fatty acids, 3% sodium salt of the fatty acids, 2% free diethanolamine
- Lot/batch No.: 13

Test animals / tissue source

Species:

rabbit

Strain:

other: Small White Russian Chbb-SPF

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.3 - 2.5 kg
- Housing: Single animals in steel cages
- Diet (e.g. ad libitum): K4 diet for rabbits, Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): yes
- Acclimation period: 14 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1°C
- Humidity (%): 60 +/- 5%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 23-01-1990 To: 09-02-1990

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: Right eye of each animal was untreated and served as control

Duration of treatment / exposure:

72 h

Observation period (in vivo):

17 d

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: Not applicable

Score:

34.9

Max. score:

110

Reversibility:

fully reversible

Remarks on result:

other: Moderately irritating

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: Not applicable

Score:

1.33

Reversibility:

fully reversible within: 10 d

Remarks on result:

other: 2/3 animals showed corneal opacity, reversible within 10 days

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

other: Not applicable

Score:

0.56

Reversibility:

fully reversible within: 10 d

Remarks on result:

other: 2/3 animals showed redness and circumcorneal injection, reversible within 10 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: Not applicable

Score:

1.11

Reversibility:

fully reversible within: 13d

Remarks on result:

other: 3/3 animals showed light swellingof the conjunctivae, reversible within 13 days

Results 5

Irritation parameter:

other: Erythema score

Basis:

mean

Time point:

other: Not applicable

Score:

2.77

Reversibility:

fully reversible within: 13 d

Remarks on result:

other: 3/3 animals showed strong erythema, reversible within 13 days

Other effects:

No details provided

Applicant's summary and conclusion

Interpretation of results:

Category II

Remarks:

Migrated information Irritating to eyes Criteria used for interpretation of results: EU

Conclusions:

Under the study conditions, the test substance was considered to be moderately irritating to the rabbit eye. Further, according to CLP, the test substance may be considered to be Category 2 eye irritant.

Executive summary:

A study was conducted to determine the irritation potential of the test substence to rabbit eye according to OECD Guideline 405.

The test substance was applied neat to the left eye of three rabbits. Animals were then observed for 17 days.

Two out of three animals showed opacity of the cornea as well as slight corneal reddening and circumcorneal injection. These effects were reversible within 10 days. In all animals, moderate to strong erythema and slight swelling of the conjunctivae were noted. This was reversible within 13 days. The overall irritation index was 34.9/110.

Under the conditions of this study, the test substance was considered moderately irritating to rabbit eye. Further, according to CLP, the test substance may be considered to be Category 2 eye irritant.