Tall oil, reaction products with ethanolamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 December 2014 to 08 January 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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:

yes

Remarks:

Due to technician error the initial pain reaction was not recorded for the first treated animal. This deviation was considered not to affect the purpose or integrity of the study.

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

Due to technician error the initial pain reaction was not recorded for the first treated animal. This deviation was considered not to affect the purpose or integrity of the study.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Tall oil, reaction products with ethanolamine

IUPAC Name:

Tall oil, reaction products with ethanolamine

Test material form:

semi-solid (amorphous): gel

Details on test material:

- Purity: 100%
- Physical state/Appearance: Brown gel
- Storage Conditions: Room temperature in the dark

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Start of the study the animals weighed 2.30 or 2.85 kg and were twelve to twenty weeks old.
Acclimatization period of at least five days.
Individually housed in suspended cages.
Free access to mains drinking water and food.
The temperature and relative humidity were set to achieve limits of 17 to 23°C and 30 to 70% respectively.
THe rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye serves as control

Amount / concentration applied:

0.1 mL of test item

Duration of treatment / exposure:

No rinse.

Observation period (in vivo):

Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment.
An additional observation was made on Day 7 to assess the reversibility of the ocular effects.

Number of animals or in vitro replicates:

2

Details on study design:

Only animals free of ocular damage were used.
The left eye remained untreated and was used for control purposes. Immediately after administration of the test item, an assessment of the initial pain reaction was made.

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 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: 74897 (male)

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

mean score

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

other: 74897 (male)

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Remarks:

mean score

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: 74897 (male)

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

mean score

Time point:

other: 24, 48 and 72 hours

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: 74897 (male)

Results 5

Irritation parameter:

cornea opacity score

Remarks:

opacity

Basis:

animal #2

Remarks:

mean score

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: 74903 (male)

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

mean score

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

other: 74903 (male)

Results 7

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Remarks:

mean score

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: 74903 (male)

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

mean score

Time point:

other: 24, 48 and 72 hours

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: 74903 (male)

Irritant / corrosive response data:

No corneal effects were noted during the study.
Iridial inflammation was noted in one treated eye 1 hour after treatment.
Moderate conjunctival irritation was noted in both treated eyes 1 hour after treatment. Moderate conjunctival irritation was noted in one treated eye with minimal conjunctival irritation noted in the other treated eye at the 24-Hour observation. Minimal conjunctival irritation was noted in both treated eyes at the 48-Hour observation.
Both treated eyes appeared normal at the 72-Hour observation.

Other effects:

One animal showed no gain in body weight and the other animal showed expected gain in body weight during the study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The eye irritancy potential of the test item was assessed in accordance with OECD Guideline 405. The test item produced a maximum group mean score of 0.0 for cornea opacity, of 0.0 for iris damage, of 1.00 for conjunctival redness and 0.66 for conjunctival chemosis. As such, the test item did not met the GHS criteria for classification.

Executive summary:

Introduction

The study was performed in accordance with OECD OECD Guideline No. 405 and EU Method B.5 to assess the irritancy potential of the test item to the eye of the New Zealand White rabbit.

Results

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

Conclusion

The test item produced a maximum group mean score of 0.0 for cornea opacity, of 0.0 for iris damage, of 1.00 for conjunctival redness and 0.66 for conjunctival chemosis; the conclusion is that the substance is not irritating.