Oxirane, mono[(C10-16-alkyloxy)methyl] derivs.

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:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Study period:

From 1990-08-14 to 1990-11-09

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Cited from ECHA disseminated dossier Query date: 2015-07-22 For justification of read across please refer to IUCLID section 13.

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Qualifier:

according to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

GLP compliance:

yes

Type of study:

guinea pig maximisation test

Species:

guinea pig

Sex:

male/female

Route:

intradermal and epicutaneous

Vehicle:

other: Oleum arachidis

Concentration / amount:

Intradermal injections: 5% with oleum arachidis
Epidermal applications: 75% in vaseline
Challenge: 25% in vaseline

Route:

epicutaneous, occlusive

Vehicle:

other: Oleum arachidis

Concentration / amount:

Intradermal injections: 5% with oleum arachidis
Epidermal applications: 75% in vaseline
Challenge: 25% in vaseline

No. of animals per dose:

Control group: 5 males and 5 females
Test group: 10 males and 10 females

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

0.1 ml/site

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.1 ml/site. No with. + reactions: 0.0. Total no. in groups: 10.0.

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

0.1 ml/site

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.1 ml/site. No with. + reactions: 0.0. Total no. in groups: 10.0.

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

25 % in vaseline

No. with + reactions:

20

Total no. in group:

20

Clinical observations:

slight to moderate erythema/Edema

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 % in vaseline. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: slight to moderate erythema/Edema.

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

25 % in vaseline

No. with + reactions:

20

Total no. in group:

20

Clinical observations:

slight to moderate erythema/Edema

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 % in vaseline. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: slight to moderate erythema/Edema.

Reading:

rechallenge

Hours after challenge:

24

Group:

test chemical

Dose level:

25 % in oleum arachides

No. with + reactions:

17

Total no. in group:

20

Clinical observations:

slight to moderate erythema/Edema

Remarks on result:

other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 25 % in oleum arachides. No with. + reactions: 17.0. Total no. in groups: 20.0. Clinical observations: slight to moderate erythema/Edema.

Reading:

rechallenge

Hours after challenge:

48

Group:

test chemical

Dose level:

25 % in oleum arachides

No. with + reactions:

11

Total no. in group:

20

Clinical observations:

slight to moderate erythema/Edema

Remarks on result:

other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 25 % in oleum arachides. No with. + reactions: 11.0. Total no. in groups: 20.0. Clinical observations: slight to moderate erythema/Edema.

Sensitizing effects

Positive erythema reactions after the first challenge procedure
	after 24 hours	after 48 hours
	Positive / total ———————— % positive of total	Positive / total ———————— % positive of total
Control group
ALKYL (C13-C15)- GLYCIOYLETHER (left flank)	0 / 10 ——— 0	0 / 10 ——— 0
vehicle only (right flank)	0 / 10 ——— 0	0 / 10 ——— 0
Test group
ALKYL (C13-C15)- GLYCIOYLETHER (left flank)	20 / 20 ———— 100	20 / 20 ———— 100
vehicle only (right flank)	0 / 20 ———— 0	0 / 20 ———— 0

 

Positive erythema reactions after the second challenge procedure
	after 24 hours	after 48 hours
	Positive / total ———————— % positive of total	Positive / total ———————— % positive of total
Control group
vehicle only (left flank)	0 / 10 ——— 0	0 / 10 ——— 0
Test group
ALKYL (C13-C15)- GLYCIOYLETHER (right flank)	17 / 20 ———— 85	11 / 20 ———— 55
vehicle only (left flank)	0 / 20 ———— 0	0 / 20 ———— 0

Mortality / Viability

No death occurred during the study.

Symptoms, systemic

No systemic symptoms were observed in the animals.

Body weights

The body weight gain of the animals was not affected adversely during the study.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

This study was conducted to evaluate the potential of the test article to induce hypersensitivity in guinea pigs using the Maximization test.

For the intradermal induction phase of the study, three pairs of intradermal injections were made at the scapular skin of test group and control group as above mentioned method in which the test article was diluted to 5% with oleum arachidis. One week later, the epidermal induction started. Scapular skin was clipped and shaved free of hair. A patch was saturated with 75% the test article in vaseline and placed over the injection sites of test group and only vaseline was placed on the skin of control group.

The test and control group were challenged two weeks after the epidermal induction application. Two patches were saturated with a) 25% in Vaseline of the test article and b) with the vehicle only and applied to the left flank and right flank using the same method as for the epidermal application.

A second challenge was performed two weeks after the first challenge. The treatment procedure was similar as described for the first challenge with the exception that vehicle was applied to the left flank and 25% test article in oleum arachides was applied to the right flank.

The challenge site was evaluated 24 and 48 hours after removal of the patch. The reactions were scored on the basis of the Draize score.

The test result of the first challenge in test group showed positive erythema reactions at 24h and 48h when treated with 25% test article in Vaseline. The test result of the second challenge in test group showed positive erythema reactions at 24h and 48h when treated with 25% test article dilution in oleum arachides.

Migrated from Short description of key information:
This study was conducted according to Maximization test and the result indicated that test substance may cause skin sensitization to guinea pigs.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is considered to be classified for skin sensitization under Directive 67/548/EEC.

                               

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

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008.