Fatty acids, C8-18 and C18-unsatd., Me esters

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP - Guideline study, tested with the source substance Fatty acids, C16-18 and C18-unsatd., Me esters (CAS No. 91051-34-2). In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

guinea pig maximisation test

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18 and C18-unsatd., Me esters

EC Number:

267-015-4

EC Name:

Fatty acids, C16-18 and C18-unsatd., Me esters

Cas Number:

67762-38-3

IUPAC Name:

67762-38-3

Constituent 2

Reference substance name:

rape-oil fatty acid methyl ester

IUPAC Name:

rape-oil fatty acid methyl ester

Details on test material:

- Name of test material (as cited in study report): Rübölfettsäuremethylester
- Physical state: clear liquid
- Analytical purity: 100% active component
- Lot/batch No.: A 06097 : 92
- Expiration date of the lot/batch: October 23, 1994
- Storage condition of test material: ambient, protected from light

In vivo test system

Test animals

Species:

guinea pig

Strain:

Pirbright-Hartley

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: : Firma Winkelmann, Versuchstierzucht, Borchen, Germany
- Weight at study initiation: male: 358-488 g, female: 301-424g
- Housing: collective housing up to a maximum of 5 animals per cage (Makrolon® type IV)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days (range finding test), 12 days (main test)


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

peanut oil

Induction 2

Concentration / amount:

5%

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

peanut oil

Challenge 2

Concentration / amount:

5%

No. of animals per dose:

10 male and 10 female

Details on study design:

RANGE FINDING TESTS:
Intradermal application:
The test article was diluted with aqua ad iniect. and Freund‘s complete adjuvant (FCA; Sigma, Deisenhofen) to give a final concentration of 5 %. Two animals were employed, skin reactions being recorded 48 h after treatment. The concentration suitable for the main study was 5%.
Epidermal application:
The test article was used undiluted. A closed patch exposure was effected by means of an occlusive bandage using Hill-Top Chambers (Hill Top, Cincinnati, USA) and non-irritating tape Elastoplast® (Beiersdorf AG, Hamburg), which enveloped the whole of the animal‘s trunk. Two animals were employed and skin reactions were recorded 48 h post applicationem. The concentration suitable for the main test was 100 %.


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2, injection and dermal application
- Exposure period: 48h for dermal application
- Test groups: 3 injections: 0.1 ml FCA 50% (w/w) diluted in aqua ad iniect, 0.1 ml test article diluted in peanut oil (final concentration: 5 %), 0.1 ml test article diluted in FCA/aqua ad iniect. (final concentration: 5 %)
- Control group: the same as test groups, but without the test substance
- Site: injections symmetrically in two rows on either side of the spine, dermal application at the trunk
- Frequency of applications: 1
- Duration: injection application on day 1, dermal application on day 7
- Concentrations: 5% for injection, 100% for dermal application
- Because the test article was non-irritating at the maximum concentration in the pilot study, the area was reclipped and pretreated with 10 % sodium lauryl sulfate (SES) in vaseline 24 h before dermal application of the test article at a concentration of 100 %.

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after second induction (day 21)
- Exposure period: 24h
- Test groups: occlusive patch, TS
- Control group: occlusive patch, TS
- Site: test substance on the left flank, additionally vehicle only on the right
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48h

Positive control substance(s):

yes

Remarks:

2,4 dinitrochlorobenzene (extreme sensitizer) and benzocaine (moderate sensitizer)

Results and discussion

Positive control results:

The reaction to the positive control substances 2,4 dinitrochlorobenzene (extreme sensitizer) and benzocaine (moderate sensitizer) is tested periodically. The last test with an acceptable level was performed in October 1992.

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

100%

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.

Results 2

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

100%

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.

Results 3

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

100%

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.

Results 4

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

100%

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information No animal showed an allergic response to the test article. According to DSD and CLP Rübölfettsäuremethylester has not to classified.