Reaction mixture of hydrogenated tallow alkyl amines with sebacic acid and lithium hydroxide

Endpoint summary

Description of key information

The test substance (EC: 433-100-1) was tested for skin and eye irritation/corrosion in rabbits. It showed neither skin irritation/corrosion nor eye irritation/corrosion properties in these tests.

 

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:

1999-01-18 to 1999-01-28

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 17 July, 1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

Directive 92/69

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

June 1996

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-88353 Kißlegg
- Weight at study initiation: 2.0 to 2.1 kg
- Housing: Individually housed in ABS - plastic rabbit cages
- Diet: ad libitum, Altromin 2123 maintenance diet for rabbits, rich in crude fibre, totally pathogene free-TPF
- Water: ad libitum, tap drinking water
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 18 ±3 °C
- Humidity: 55 ± 10%
- Air changes: at least 10 x / hour
- Photoperiod: Artificial light, lighting regime 12 : 12 hours, light 6.30 - 18.30

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: Carboxymethylcellulose

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g

Duration of treatment / exposure:

4 h

Observation period:

1, 24, 48, 72 h

Number of animals:

3 female animals

Details on study design:

TEST SITE
- Area of exposure: (approx. 6 cm2) of skin
- Type of wrap if used: gauze patch, which was held in place with non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 4 hours

SCORING SYSTEM: Scoring system according to Draize

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

No skin reactions (erythema, oedema) were recorded throughout the observation period of 72 hours as compared to untreated control sites.

Interpretation of results:

GHS criteria not met

Conclusions:

The test item showed no irritant effects on the intact skin after a contact time of 4 hours.

Executive summary:

The test material was assessed for skin irritation properties according to EU Method B.4/OECD Guideline 404. The test material was applied to the intact skin of New Zealand White rabbits in a single, 4 -hour, semi-occluded application of the test material to the intact skin of three female animals. The test material produced edema scores of 0.0 after 24, 48 and 72 h and erythema scores of 0.0 after 24, 48 and 72 h in all animals and was classified as non-irritatant to the rabbit skin. No corrosive effects were noted.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not 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:

1999-02-01 to 1999-02-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 24 Feb., 1987

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Directive 92/69

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Version / remarks:

June 1996

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-88353 Kißlegg
- Weight at study initiation: 2.2 to 2.5 kg
- Housing: Individually housed in ABS - plastic rabbit cages
- Diet: ad libitum, Altromin 2123 maintenance diet for rabbits, rich in crude fibre, totally pathogene free-TPF
- Water: ad libitum, tap drinking water
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 18 ±3 °C
- Humidity: 55 ± 10%
- Air changes: at least 10 x / hour
- Photoperiod: Artificial light, lighting regime 12 : 12 hours, light 6.30 - 18.30

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 g of solid was applied to the test site

Duration of treatment / exposure:

72 h

Observation period (in vivo):

1, 24, 48, 72 h

Number of animals or in vitro replicates:

3 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no

TOOL USED TO ASSESS SCORE: fluorescein solution

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.22

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

1 hour after application a slight erythema and chemosis of the conjunctivae was visible in all animals. Slight signs of irritation were visible at the 24 h reading in all of the 3 test animals. In one animal slight erythema was also visible at the 48 hour reading. No changes were visible at the 72 h reading in any of the 3 test animals. No corneal lesions were found upon fluorescein examination at the 72 h reading. The test item produced no corrosion or irreversible effects in any of the animals.

Interpretation of results:

GHS criteria not met

Conclusions:

It can be concluded that test substance (EC: 433-100-1) does not cause eye irritation in rabbits.

Executive summary:

A study was performed to assess the Irritancy potential of the test substance (EC: 433-100-1) to the eye of the New Zealand White rabbit. The method used followed the OECD Guidelines for Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" (adopted 24 February 1987) and Method B.5 of Commission Directive 92/69/EEC. A single application of the test material at a dose of 0.1 g to the non-irrigated eye of three female rabbits was done. One hour after application a slight erythema and chemosis of the conjunctivae was visible in all animals. Slight signs of irritation were visible at the 24 h reading in all of the 3 test animals. In one animal slight erythema was also visible at the 48 hour reading. No changes were visible at the 72 h reading in any of the 3 test animals. No corneal lesions were found upon fluorescein examination at the 72 h reading. The test item produced no corrosion or irreversible effects in any of the animals. Thus, it can be concluded that the test substance (EC: 433-100-1) does not cause eye irritation in rabbits.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin Irritation:

The test material was assessed for skin irritation properties according to EU Method B.4/OECD Guideline 404. The test material was applied to the intact skin of New Zealand White rabbits in a single, 4-hour, semi-occluded application of the test material to the intact skin of three female animals. The test material produced edema scores of 0.0 after 24, 48 and 72 h and erythema scores of 0.0 after 24, 48 and 72 h in all animals and was classified as non-irritant to the rabbit skin. No corrosive effects were noted.

 

Eye irritation:

A study was performed to assess the Irritancy potential of the test substance (EC: 433-100-1) to the eye of the New Zealand White rabbit. The method used followed the OECD Guidelines for Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" (adopted 24 February 1987) and Method B.5 of Commission Directive 92/69/EEC. A single application of the test material at a dose of 0.1 g to the non-irrigated eye of three female rabbits was done. One hour after application a slight erythema and chemosis of the conjunctivae was visible in all animals. Slight signs of irritation were visible at the 24 h reading in all of the 3 test animals. In one animal slight erythema was also visible at the 48 hour reading. No changes were visible at the 72 h reading in any of the 3 test animals. No corneal lesions were found upon fluorescein examination at the 72 h reading. The test item produced no corrosion or irreversible effects in any of the animals. Thus, it can be concluded that the test substance (EC: 433-100-1) does not cause eye irritation in rabbits.

 

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on skin and eye irritation/corrosion, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the twelfth time in Regulation (EU) No 2019/521.