Fatty acids, tall-oil, compds. with diethanolamine

Endpoint summary

Description of key information

Skin irritation

A study was conducted to determine the irritation potential of the test substance, C16-18 and C18-unsatd. DEA, to rabbit skin according to OECD Guideline 404. The substance was applied undiluted to rabbit skin under an occlusive bandage for 4 h, then washed with warm water. Animals were observed for 25 d. Strong erythema and strong oedema were recorded in all animals. Slow recovery occurred, under thick scabs. After 25 d, 2/3 of the animals had fully recovered. In the third animal, scabs were falling away. The overall irritation index was 7/8 so that the undiluted test substance was considered highly irritating to rabbit skin under the conditions of the study (Mürmann, 1990).

Eye irritation

A study was conducted to determine the irritation potential of the test substance, C16-18 and C18-unsatd. DEA, to rabbit eyes according to OECD Guideline 405. The substance was applied neat to the left eye of three rabbits; the right eye served as untreated control. Animals were then observed for 17 d. Two out of three animals showed opacity of the cornea as well as slight corneal reddening and circum-corneal injection. These effects were reversible within 10 d. In all animals, moderate to strong erythema and slight swelling of the conjunctivae were noted. This was reversible within 13 d. The overall irritation index was 34.9/110. Under the study conditions, the test substance was considered to be irritating to rabbit eyes (Mürmann, 1990).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From January 9, 1990 to February 14, 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Species:

rabbit

Strain:

other: Small White Russian Chbb-SPF

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.5 - 2.8 kg
- Housing: Single animals in steel cages
- Diet (e.g. ad libitum): K4 diet for rabbit, 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: 11-01-1990 To: 05-02-1990

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 cm3 of product on a 6 cm2 skin surface
- Concentration (if solution): undiluted

Duration of treatment / exposure:

4 h

Observation period:

25 d

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm2
- % coverage: 100%
- Type of wrap if used: application site covered with gauze. Additional wWrapping with an elastic band.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 4 h

SCORING SYSTEM: OECD 404 method

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: Not applicable

Score:

7

Max. score:

8

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 3.67

Max. score:

4

Reversibility:

other: Slow recovery occurred, under thick scabs. After 25 d, 2/3 of the animals had fully recovered. In the third animal, scabs were falling away.

Remarks on result:

positive indication of irritation

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 4

Max. score:

4

Reversibility:

other: Slow recovery occurred, under thick scabs. After 25 d, 2/3 of the animals had fully recovered. In the third animal, scabs were falling away.

Remarks on result:

positive indication of irritation

Strong erythema and strong oedema were observed in all animals. Slow recovery occured, under thick scabs. After 25 days, 2/3 animals had fully recovered. In the third animal, scabs were falling away.

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Under the conditions of the study, the undiluted test substance was considered to be highly irritating to rabbit skin.

Executive summary:

A study was conducted to determine the irritation potential of the test substance, C16-18 and C18-unsatd. DEA, to rabbit skin according to OECD Guideline 404. The substance was applied undiluted to rabbit skin under an occlusive bandage for 4 h, then washed with warm water. Animals were observed for 25 d. Strong erythema and strong oedema were recorded in all animals. Slow recovery occurred, under thick scabs. After 25 d, 2/3 of the animals had fully recovered. In the third animal, scabs were falling away. The overall irritation index was 7/8 so that the undiluted test substance was considered highly irritating to rabbit skin under the conditions of the study (Mürmann, 1990).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

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

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

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

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 1.33

Max. score:

4

Reversibility:

fully reversible within: 10 d

Remarks on result:

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

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0.56

Max. score:

2

Reversibility:

fully reversible within: 10 d

Remarks on result:

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

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 1.11

Max. score:

4

Reversibility:

fully reversible within: 13d

Remarks on result:

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

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 2.77

Max. score:

3

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.

None.

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Under the study conditions, the test substance was considered irritating to rabbit eyes.

Executive summary:

A study was conducted to determine the irritation potential of the test substance, C16-18 and C18-unsatd. DEA, to rabbit eyes according to OECD Guideline 405. The substance was applied neat to the left eye of three rabbits; the right eye served as untreated control. Animals were then observed for 17 d. Two out of three animals showed opacity of the cornea as well as slight corneal reddening and circum-corneal injection. These effects were reversible within 10 d. In all animals, moderate to strong erythema and slight swelling of the conjunctivae were noted. This was reversible within 13 d. The overall irritation index was 34.9/110. Under the study conditions, the test substance was considered to be irritating to rabbit eyes (Mürmann, 1990).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Skin

Based on an in vivo skin irritation study, a 4 hour occlusive exposure to undiluted test substance leads to an irritation response. On the basis of this study, the substance was classified as Skin Irrit. 2 - H315 (causes skin irritation) according to CLP (EC 1272/2008) criteria.

Eye

Based on an in vivo eye irritation study, instillation of undiluted test substance into rabbit eyes is clearly irritating. Since the effects seen in this study were reversible, the substance was classified as Eye irrit. 2 - H319 (causes serious eye irritation) according to CLP (EC 1272/2008) criteria.