Fatty acids, tall-oil, reaction products with acrylic acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

6 animals instead of 3

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Diacid 1550

IUPAC Name:

Diacid 1550

Constituent 2

Reference substance name:

C21 Dicarboxylic Fatty Acid

IUPAC Name:

C21 Dicarboxylic Fatty Acid

Constituent 3

Reference substance name:

5(or 6)-carboxy-4-hexylcyclohex-2-ene-1-octanoic acid

EC Number:

258-897-1

EC Name:

5(or 6)-carboxy-4-hexylcyclohex-2-ene-1-octanoic acid

Cas Number:

53980-88-4

Molecular formula:

C21H36O4

IUPAC Name:

5-(7-carboxyheptyl)-2-hexylcyclohex-3-ene-1-carboxylic acid

Details on test material:

- Name of test material (as cited in study report): Diacid 1550 Tall Oil Fatty Acid (C21 Dicarboxylic Fatty Acid)
- Physical state: Liquid
- Lot/batch No.: No data
- Storage condition of test material: Ambient temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: S&S Associates
- Age at study initiation: young adult
- Weight at study initiation: 2.3-3.5 kg
- Housing: Housed individually in stainless steel pens with raised flooring suspended over drip pans lined with absorbent paper bedding.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.3-23.8
- Humidity (%): 40-60
- Air changes (per hr): conditioned room
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted (100%)

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

1 hour after installation, and 24, 48 and 72 hours after, and thereafter daily for 21 days

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): flushing
- Time after start of exposure: 24 hours

SCORING SYSTEM: The numerical scorings recorded were made in compliance with OECD guideline 405, 1992, scoring ocular lesions (corneal, iridic and conjunctival irritation, and discharge).

TOOL USED TO ASSESS SCORE: No data

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

6 animals

Time point:

24 h

Score:

ca. 0.16

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: 3 animals exhibited fibrovascular connective tissue (an indication of corrosion)

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

6 animals

Time point:

48 h

Score:

ca. 0.5

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: 3 animals exhibited fibrovascular connective tissue (an indication of corrosion)

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

6 animals

Time point:

72 h

Score:

ca. 0.66

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: 3 animals exhibited fibrovascular connective tissue (an indication of corrosion)

Results 4

Irritation parameter:

iris score

Basis:

mean

Remarks:

6 animals

Time point:

24 h

Score:

ca. 0.16

Max. score:

2

Reversibility:

fully reversible within: 21 days

Results 5

Irritation parameter:

iris score

Basis:

mean

Remarks:

6 animals

Time point:

48 h

Score:

ca. 0.16

Max. score:

2

Reversibility:

fully reversible within: 21 days

Results 6

Irritation parameter:

iris score

Basis:

mean

Remarks:

6 animals

Time point:

72 h

Score:

ca. 0.16

Max. score:

2

Reversibility:

fully reversible within: 21 days

Results 7

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

6 animals

Time point:

24 h

Score:

ca. 2.66

Max. score:

3

Reversibility:

fully reversible within: 21 days

Results 8

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

6 animals

Time point:

48 h

Score:

ca. 2

Max. score:

3

Reversibility:

fully reversible within: 21 days

Results 9

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

6 animals

Time point:

72 h

Score:

ca. 1.66

Max. score:

3

Reversibility:

fully reversible within: 21 days

Results 10

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

6 animals

Time point:

24 h

Score:

ca. 2.66

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 11

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

6 animals

Time point:

48 h

Score:

ca. 2.16

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 12

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

6 animals

Time point:

72 h

Score:

ca. 2.16

Max. score:

4

Reversibility:

fully reversible within: 21 days

Irritant / corrosive response data:

Immediately after dosing, all 6 test animals displayed pawing and rubbing of the test eye. 24 hours after dosing, 1 test animal displayed corneal irritation with scattered or diffuse areas of opacity but details of iris still clearly visible. By 48 hours, 3 more animals developed this type of corneal opacity. By Day 7, 2 of these 3 animals exhibited fibrovascular connective tissue (an indication of corrosion) and a third test animal developed it on Day 10. The remaining 3 test animals showed complete recovery or significant improvement by Day 21.
During the 72-hour observation period, 3 test animals exhibited markedly deepened folds, congestion, swelling, moderate circumcorneal injection with iris still reacting to light. On Day 7, a fourth animal developed the same type of irritation and one animal recovered from the irritation.
One hour after dosing, all 6 test animals displayed conjunctivae irritation. This irritation ranged from some vessels definitely injected to diffuse, crimson red, individual vessels not easily discernible. 5 of the 6 test animals' irritation became more severe by 24 hours. Complete recovery or slight recovery was observed in 3 of the animals by Day 21.
One hour after dosing, all 6 test animals exhibited chemosis, ranging from swelling with lids about half closed to swelling with lids more than half closed. This swelling improved slightly by 24 hours, in 4 of the 6 test animals. Recovery was observed in 3 of the test animals by Day 10.
One hour after dosing, 2 of the 6 test animals displayed slight discharge (any amount different from normal). At 24 hours after dosing, another 3 test animals exhibited discharge ranging from any amount different than normal to discharge with moistening of the lids and hairs, and considerable area around the eye. At Day 7, hair loss around the test eye was observed in one test animal. Additionally, 2 test animals developed a bloody discharge by Day 10. Complete recovery was observed in 3 of the 6 test animals by Day 21.

Other effects:

Not relevant

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

When tested as specified, the submitted test substance, Diacid 1550 Tall Oil Fatty Acid, induced eye irritation in all 6 test rabbits. The average mean scores calculated from the numerical values given to the eye irritation observed at the 24, 48, and 72 hour examinations of the 6 rabbits were 0.16, 0.5, and 0.66 for corneal irritation, and 0.16 for iris irritation, 2.66, 2.0, and 1.66 for conjunctivae (redness) irritation, and 2.66, 2.16, and 2.16 for chemosis. Fibrovascular connective tissue (an indication of corrosion) was observed in 2 of the test animals by Day 7 and a third by Day 10. Complete recovery or slight recovery was observed in the remaining 3 test animals by Day 21. Based on these results and according to the EU criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EC (CLP/EU-GHS), Diacid 1550 Tall Oil Fatty Acid has to be classified and labeled as corrosive to the eyes.

Executive summary:

The primary eye irritation potential of Diacid 1550 Tall Oil Fatty Acid was investigated according to OECD test guideline no. 405, 1992. The test item was applied by instillation of 0.1 ml into one eye of each of 6 young adult New Zealand White rabbits for 24 hours. Scoring of irritation effects was performed approx. 1, 24, 48 and 72 hours after test item instillation, in compliance with OECD 405, scoring ocular lesions (corneal, iridic and conjunctival irritation, and discharge). Observation period was 21 days. When tested as specified, the submitted test substance, Diacid 1550 Tall Oil Fatty Acid, induced eye irritation in all 6 test rabbits. The average mean scores calculated from the numerical values given to the eye irritation observed at the 24, 48, and 72 hour examinations of the 6 rabbits were 0.16, 0.5, and 0.66 for corneal irritation, and 0.16 for iris irritation, 2.66, 2.0, and 1.66 for conjunctivae (redness) irritation, and 2.66, 2.16, and 2.16 for chemosis. Fibrovascular connective tissue (an indication of corrosion) was observed in 2 of the test animals by Day 7 and a third by Day 10. Complete recovery or slight recovery was observed in the remaining 3 test animals by Day 21. Based on these results and according to the EU criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EC (CLP/EU-GHS), Diacid 1550 Tall Oil Fatty Acid has to be classified and labeled as corrosive to the eyes.