12-hydroxyoctadecanoic acid, reaction products with 1,3-benzenedimethanamine and hexamethylenediamine

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

yes

Remarks:

Some temperature and humidity were outside the range. Sodium lauryl sulphate have not been applicated and the test substance concentration was not irritating (70% w/v concentration as the possible maximum soluble concentration) after topical induction.

Qualifier:

according to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2600 (Skin Sensitisation)

Principles of method if other than guideline:

Not applicable

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

male

Route:

intradermal and epicutaneous

Route:

epicutaneous, occlusive

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

10 % w/v

No. with + reactions:

0

Total no. in group:

5

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10 % w/v. No with. + reactions: 0.0. Total no. in groups: 5.0.

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

10 % w/v

No. with + reactions:

0

Total no. in group:

5

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10 % w/v. No with. + reactions: 0.0. Total no. in groups: 5.0.

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

10 % w/v

No. with + reactions:

2

Total no. in group:

10

Clinical observations:

Dryness and sloughing of the epidermis in 4 animals

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 % w/v. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: Dryness and sloughing of the epidermis in 4 animals.

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

10 % w/v

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

Dryness and sloughing of the epidermis in 2 animals

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 % w/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Dryness and sloughing of the epidermis in 2 animals.

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

5 % w/v

No. with + reactions:

0

Total no. in group:

5

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5 % w/v. No with. + reactions: 0.0. Total no. in groups: 5.0.

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

5 % w/v

No. with + reactions:

0

Total no. in group:

5

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5 % w/v. No with. + reactions: 0.0. Total no. in groups: 5.0.

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

5 % w/v

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

Dryness and sloughing of the epidermis in 2 animals

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 % w/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Dryness and sloughing of the epidermis in 2 animals.

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

5 % w/v

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

Dryness and sloughing of the epidermis in 2 animals

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5 % w/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Dryness and sloughing of the epidermis in 2 animals.

Parameter:

SI

Remarks on result:

other: Not applicable

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: Not applicable

Table 7.4.1/1: Dermal reactions observed after the challenge application with E96095

Animal No.	24 Hours				48 Hours				Results
	Erythema		Oedema		Erythema		Oedema
	A	P	A	P	A	P	A	P	-
1735	0	0	0	0	0	0*	0	0	-
1736	0	0	0	0	0	0	0	0	-
1737	0*	0	0	0	0*	0	0	0	-
1738	0	0	0	0	0	0	0	0	-
1739	0	0	0	0	0	0	0	0	-
1740	1*	0*	0	0	0*	0	0	0	±
1741	0	0*	0	0	0	0	0	0	-
1742	0*	0	0	0	0	0	0	0	-
1743	0	0	0	0	0	0	0	0	-
1744	1*	0	0	0	0	0	0	0	±

* Dryness and sloughing of the epidermis

A Anterior site, exposed to E96095, 10 % w/v in Alembicol D

P Posterior site, exposed to E96095, 5 % w/v in Alembicol D

Clinical signs

No sign of toxicity were observed

Bodyweight

Bodyweight increases were recorded for all guinea-pigs over the period of the study

Induction

Intradermal injections:

Necrosis were recorded at sites received Freund's Complete Adjuvant in test and control animals.

Slight irritation was seen in test animals at sites receiving E96095, 5 % w/v in Alembicol D and slight irritation was observed in control animals receiving Alembicol D.

Topical application:

No erythema was observed in test animals following topical application with E96095, 70 % w/v in Alembicol D.

No erythema was seen in the control guinea-pigs

Challenge

There were no dermal reactions seen in 8 of the 10 test animals or in any of the control animals. The remaining 2 animals gave inconclusive response.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

In a dermal sensitization study with E96095 in Alembicol D, performed according to the OECD guideline No 406 and in compliance with GLP, 10 healthy male albino guinea-pigs were tested using the guinea-pig maximisation test method. The highest not irritant test concentration (50%) and the lowest irritant test concentration (70%) were determined in the preliminary study.

The control animals showed the anticipated reactions. No dermal reactions were seen in 8 of the 10 test animals and the remaining two animals gave inconclusive response.

Migrated from Short description of key information:
In a dermal sensitization study with E96095 in Alembicol D, performed according to the OECD guideline No 406 and conducted in compliance with GLP, no dermal reactions were observed in 8 of the 10 test animals and the remaining two animals gave inconclusive response. E96095 is not classified according to the CLP Regulation (1272/2008).

Justification for selection of skin sensitisation endpoint:
Study performed according to the OECD guideline 406 and GLP compliant

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

No data

Migrated from Short description of key information:
No data

Justification for classification or non-classification

As no dermal reactions were seen in 8 of the 10 test animals in a dermal sensitization study with E96095, performed according to the OECD guideline No 406 and in compliance with GLP, E96095 is not classified according to the CLP Regulation (1272/2008).