Reaction product of C16-22, even, C18-rich, unsaturated and saturated triglycerides with, N-(2-hydroxypropylamine)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 December 2014 to 06 May 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction product of C16-22, even, C18-rich, unsaturated and saturated triglycerides with, N-(2-hydroxypropylamine)

Molecular formula:

Too Complex

IUPAC Name:

Reaction product of C16-22, even, C18-rich, unsaturated and saturated triglycerides with, N-(2-hydroxypropylamine)

Details on test material:

- Physical state: Dark yellow viscous liquid
- Analytical purity: 100 %
- Expiration date of the lot/batch: 12 June 2016
- Storage condition of test material: Room temperature in the dark

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

ANIMALS AND ANIMAL HUSBANDRY
- Two New Zealand White rabbits (Hsdlf:NZW) were supplied by Harlan Laboratories UK Ltd, Leicestershire, UK
- At the start of the study the animals weighed 2.56 kg or 2.74 kg and were 12 to 20 weeks old.
- After an acclimatisation period of at least 5 days each animal was given a number unique within the study, which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.
- Animals were individually housed in suspended metal cages.
- Free access to mains drinking water and food (2930C Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd, Oxon UK) was allowed throughout the study.
- The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
- Temperature and relative humidity were set to achieve limits of 17 °C to 23 °C and 30 % to 70 % respectively.
- The rate of air exchange was at least 15 changes per hour.
- Lighting was controlled by a time switch to give 12 hours continuous light (06:00 to 18:00) and 12 hours darkness.
- Animals were provided with environmental enrichment items, which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

Two

Details on study design:

TEST ITEM FORMULATION AND EXPERIMENTAL PREPARATION
- The test item was used as supplied.
- Absorption of the test material was not determined.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

opacity

Basis:

animal #1

Remarks:

mean score

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: 74921 (male)

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

mean score

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

other: 74921 (male)

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Remarks:

mean score

Time point:

other: 24, 48 and 72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: 74921 (male)

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

mean score

Time point:

other: 24, 48 and 72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: 74921 (male)

Results 5

Irritation parameter:

cornea opacity score

Remarks:

opacity

Basis:

animal #2

Remarks:

mean score

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: 74944 (male)

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

mean score

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

other: 74944 (male)

Results 7

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Remarks:

mean score

Time point:

other: 24, 48 and 72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: 74944 (male)

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

mean score

Time point:

other: 24, 48 and 72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: 74944 (male)

Irritant / corrosive response data:

- Individual and group mean scores for ocular irritation are given in Table 1 and Table 2 (attached).

Any other information on results incl. tables

MEASUREMENT OF pH

- Aqueous preparation of the test item (10 % w/w): pH 8.62 immediately; pH 8.31 after 10 minutes.

OCULAR REACTIONS

- No corneal or iridial effects were noted during the study.

- Moderate conjunctival irritation was noted in both treated eyes one hour after treatment with minimal conjunctival irritation noted at the 24 and 48 hour observations.

- Both treated eyes appeared normal at the 72 hour observation.

BODY WEIGHT

- Individual body weights and body weight change are given in Table 3 (attached).

- One animal showed body weight loss and the other animal showed expected gain in body weight during the study.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item produced a maximum group mean score of 11.0 and was considered to be a mild irritant to the rabbit eye according to a modified Kay and Calandra system (Class 4 on a 1 to 8 scale). However, the test material is not classified under the terms of Regulation (EC) No 1272/2008.

Executive summary:

GUIDELINE

The study was performed in accordance with OECD Guideline for the Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" (adopted 02 October 2013) and Method B.5 Acute Toxicity (Eye Irritation) of Commission Regulation (EC) No. 440/2008.

RESULTS

A single application of the test item to the non-irrigated eye of two rabbits produced moderate conjunctival irritation. Both treated eyes appeared normal at the 72 hour observation.

CONCLUSION

The test item produced a maximum group mean score of 11.0 and was considered to be a mild irritant to the rabbit eye according to a modified Kay and Calandra system (Class 4 on a 1 to 8 scale). However, the test material is not classified under the terms of Regulation (EC) No 1272/2008.