Fatty acids, tall-oil, iron salts

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 September 2005 - 7 October 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Justification for read-across, see attached file.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Tall oil

EC Number:

232-304-6

EC Name:

Tall oil

Cas Number:

8002-26-4

Molecular formula:

Not applicable - UVCB substance

Test material form:

liquid: viscous

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL

Observation period (in vivo):

1, 24, 48 and 72 hours p.a

Number of animals or in vitro replicates:

3 females

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Results 3

Irritation parameter:

other: Redness

Basis:

mean

Time point:

24/48/72 h

Score:

0

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible

Irritant / corrosive response data:

The mean irritation parameters are 0,0 in scoring for all parametres. However, the scoring for the first hour for all animals is 1 except for chemosis where one out of three had scoring 0,0. Redness in the Conjunctivae area were associated with discharge with moistening of the lids and hairs just adjacent to the lids.

No signs of irritation was seen after 1h.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Conclusion
The mean scores were calculated for each animal was 0,0 from the examinations 24 h,  48 h and 72 h p.a.

Executive summary:

Aim of the study

The aim of this study was to investigate possible irritating or corrosive effects of the pure test substance following a single administration into a conjunctival sac of rabbits.

Methods

Methods and investigations were performed in accordance with the OECD-Guideline 405 and the Directive 2004/73/EC, method B.5.

Administration of the test substance

0.1 mL of "CRUDE TALL OIL" was instilled into the conjunctival sac of one eye of each of 3 New Zealand White rabbits. Firstly the test substance was administered to one animal. As there was no corrosive or severe irritant effect observed, the test substance was administered to two additional animals one week later.

Investigations

• Body weights: at the start and at the termination of the test.

• General signs of toxicity: once daily.

• Eye examinations: 1, 24, 48 and 72 h after the administration (p.a.) of the test substance.

Results

General signs of toxicity

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Eye examinations

• Corneae and Irises: Not affected.  
• Conjunctivae, redness: Some injected blood vessels (score "1") were observed in all animals only 1 h p.a.
• Conjunctivae, chemosis: Very slight swelling (score "1") was observed in 2/3 animals only 1 h p.a.
• Additional findings: Ocular discharge was noted in all animals 1 h p.a.

Conclusion

The mean scores were calculated for each animal was 0,0 from the examinations 24 h,  48 h and 72 h p.a.