bis(hydrogenated tallow C16-18-alkyl)hydroxylamine

Endpoint summary

Description of key information

There was no evidence for a skin and eye irritation potential of the test item.

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:

1995-06-06 to 1995-09-20

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:

24 February 1987

Deviations:

yes

Remarks:

Occlusive treatment was used. This has no impact on the realibility of the study.

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

31 July 1992

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GMBH; Chemisch-pharmazeutische Fabrik; D-88397 Biberach
- Age at study initiation: 2 to 3 month
- Weight at study initiation: 2410 to 2500 g
- Housing: individually in metal cages
- Diet: standard rabbit pellet - Nafag No. 814, Gossau, Switzerland, ad libitum
- Water: fresh water ad libitum
- Acclimation period:at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 2 0 ± 3 °C
- Humidity: relative humidity of 30-70 %
- Air changes (per hr): not stated
- Photoperiod: 12 hours light cycle day.

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g

VEHICLE
- Amount(s) applied: patches were moistened with the vehicle

Duration of treatment / exposure:

4 hours

Observation period:

- 72 hours; extended to 7 days
- skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: 12 - 16 cm² at the flank of the animals
- Type of wrap: patch covered with aluminium foil and hold in place with adhesive plast (Isoplast) wrapping

REMOVAL OF TEST SUBSTANCE
- Washing: none

SCORING SYSTEM: OECD guideline No. 404

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Slight erythema (score 1) was recorded in all rabbits 1 and 24 hours after gauze patch removal and in one animal up to 72 hours.
Because reactions were observed within 3 days after removing the bandages, the observation period was extended to 7 days to determine the reversibility of the skin reactions. On day 7, skin reactions were fully reversed in all animals.

Interpretation of results:

GHS criteria not met

Conclusions:

The test item caused minimal irritation below the threshold of significance and is therefore considered to be not irritating.

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:

1995-06-14 to 1995-07-24

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

31 July 1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

24 February 1987

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GMBH; Chemisch-pharmazeutische Fabrik; D-88397 Biberach
- Age at study initiation: no data
- Weight at study initiation: :2150 to 2290 g
- Housing: individually in metal cages
- Diet: standard rabbit pellet - Nafag No. 814, Gossau, Switzerland, ad libitum
- Water: fresh water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 2 0 ± 3°C
- Humidity: relative humidity of 30-70 %
- Air changes (per hr): no data
- Photoperiod: 12 hours light cycle day.

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL corresponding to about 52 mg

Duration of treatment / exposure:

contineous

Observation period (in vivo):

72 hours (eye reactions were scored 1, 24, 48, and 72 hours after instillation)

Number of animals or in vitro replicates:

3 females

Details on study design:

REMOVAL OF TEST SUBSTANCE: the test substance was not removed

SCORING SYSTEM: eye reactions were scored according to OECD Guideline 405

TOOL USED TO ASSESS SCORE: Not indicated

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

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 h

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Minimal conjunctivae redness (score 1) was observed in 2 animals at 24-hour-reading after test item instillation.

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance is not irritating in the rabbit eye.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin

A GLP-compliant skin irritation test was performed with three New Zealand White rabbits according to OECD 404. The animals were treated semiocclusively with approximately 0.5 g of the test material moistened with 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80. Slight erythema (score 1) was recorded in all rabbits 1 and 24 hours after gauze patch removal and in one animal up to 72 hours. On day 7, skin reactions were fully reversed in all animals. No edema were recorded. The mean scores for the 24, 48 and 72 h reading for erythema and edema were well below the threshold of significance. As a result, the test article is regarded to be not irritating to the rabbit skin.

 

Eye

A GLP-compliant eye irritation test was performed with three New Zealand White rabbits according to OECD 405. Single samples of approximately 52 mg of the test article (a volume of approximately 0.1 ml) were instilled into one eye of each of the three rabbits. Ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation according to the OECD scoring system. Minimal conjunctivae redness (score 1) was observed in 2 animals at the 24-hour-reading after test item instillation. The observed eye reactions were completely reversed in all rabbits on day 2. The scores recorded were well below the threshold of significance. In conclusion, based on the data presented, the test substance is not irritating to the eye of New Zealand White rabbits.

Justification for classification or non-classification

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

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No 1272/2008. Based on the data, classification for irritation is not warranted under Regulation (EC) No 1272/2008,as amended for the eighth time in Regulation (EU) No 2016/218.