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Toxicological information

Skin sensitisation

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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:
weight of evidence
Study period:
02 Dec 1992 - 07 Jan 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP guideline study, tested with the source substance CAS 67762-38-3. According 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:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted in 1981
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Rübölfettsäuremethylester
- Physical state: clear liquid
- Analytical purity: 100%
- Batch Nr.: A 06097:92
- Expiration date of the batch: 23.10.1994
- Storage condition of test material: room temperature, protected from light

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright white
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Substrain as given in report: Bor: DHPW (SPF)
- Source: Winkelmann Versuchstierzucht, Germany
- Age at study initiation: approx. 5 weeks
- Weight at study initiation: 358 - 488 g (males), 301 - 424 g (females)
- Housing: groups of 5 animals in Makrolon type IV cages
- Diet: Ssniff-G diet for guinea pigs, ad libitum
- Water: ad libitum
- Acclimation period: 7 days for range finding pretest, 12 days for main test

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
peanut oil
Concentration / amount:
- Induction, intradermal injection: 5% test item in peanut oil
- Induction, epidermal: 100% test item
- Challenge: 100% test item
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
peanut oil
Concentration / amount:
- Induction, intradermal injection: 5% test item in peanut oil
- Induction, epidermal: 100% test item
- Challenge: 100% test item
No. of animals per dose:
20
Details on study design:
RANGE FINDING PRETEST
- Intradermal injection: the test item was injected at a concentration of 5% in aqua ad inject. and Freund's complete adjuvant (FCA) in each of 2 animals; skin reaction was recorded after 48 h. Since no skin reaction was noticed, 5% was found to be suitable for intradermal injection.
- Epidermal application: the test item was applied undiluted onto the skin of each of the 2 animals under occlusive conditions; skin reaction was recorded after 48 h. Since no skin reaction was noticed, 100% was found to be suitable for epidermal application.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: Intradermal induction on day 1 and epidermal induction at day 8 (for 24 h)
- Test groups: 20 animals, treated with test item
- Control group: 20 animals treated with vehicle only
- Site: the scapular region of both sides
- Frequency of applications: once
- Duration: 3 weeks
- Concentrations: 5% dilution of the test substance in peanut oil was used for intradermal induction and 100% used for epidermal induction
- Pretreatment: skin was pretreated with sodium lauryl sulfate (SLS, 10% in vaseline) 24 h prior to epidermal induction

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 14 after epidermal induction (day 22)
- Exposure period: 24 h
- Test groups: 20 animals, treated with test item
- Control group: 20, treated with test item
- Site: one sheared flank
- Concentrations: 100%
- Evaluation (hr after challenge):24 and 48 h

SCORING
Scoring of skin findings was based on the Draize System
Positive control substance(s):
yes
Remarks:
2,4 dinitrochlorobenzene and benzocaine

Results and discussion

Positive control results:
periodically tested, last test with acceptable level of response: October 1992

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
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. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
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. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
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. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
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. Clinical observations: none.

Any other information on results incl. tables

Individual challenge readings:

Animal No.

Sex

Day 24

Day 25

Comments

100%

Vehicle

100%

Vehicle

Ery.

Ed.

Ery.

Ed.

Ery.

Ed.

Ery.

Ed.

Control

1

Male

0

0

0

0

0

0

0

0

 none

2

Male

0

0

0

0

0

0

0

0

 none

3

Male

0

0

0

0

0

0

0

0

none 

4

Male

0

0

0

0

0

0

0

0

 none

5

Male

0

0

0

0

0

0

0

0

 none

6

Male

0

0

0

0

0

0

0

0

 none

7

Male

0

0

0

0

0

0

0

0

 none

8

Male

0

0

0

0

0

0

0

0

 none

9

Male

0

0

0

0

0

0

0

0

 none

10

Male

0

0

0

0

0

0

0

0

 none

11

Female

0

0

0

0

0

0

0

0

 none

12

Female

0

0

0

0

0

0

0

0

 none

13

Female

0

0

0

0

0

0

0

0

 none

14

Female

0

0

0

0

0

0

0

0

 none

15

Female

0

0

0

0

0

0

0

0

 none

16

Female

0

0

0

0

0

0

0

0

 none

17

Female

0

0

0

0

0

0

0

0

 none

18

Female

0

0

0

0

0

0

0

0

 none

19

Female

0

0

0

0

0

0

0

0

 none

20

Female

0

0

0

0

0

0

0

0

 none

Treated

1

Male

0

0

0

0

0

0

0

0

Not sensitized

2

Male

0

0

0

0

0

0

0

0

Not sensitized

3

Male

0

0

0

0

0

0

0

0

Not sensitized

4

Male

0

0

0

0

0

0

0

0

Not sensitized

5

Male

0

0

0

0

0

0

0

0

Not sensitized

6

Male

0

0

0

0

0

0

0

0

Not sensitized

7

Male

0

0

0

0

0

0

0

0

Not sensitized

8

Male

0

0

0

0

0

0

0

0

Not sensitized

9

Male

0

0

0

0

0

0

0

0

Not sensitized

10

Male

0

0

0

0

0

0

0

0

Not sensitized

11

Female

0

0

0

0

0

0

0

0

Not sensitized

12

Female

0

0

0

0

0

0

0

0

Not sensitized

13

Female

0

0

0

0

0

0

0

0

Not sensitized

14

Female

0

0

0

0

0

0

0

0

Not sensitized

15

Female

0

0

0

0

0

0

0

0

Not sensitized

16

Female

0

0

0

0

0

0

0

0

Not sensitized

17

Female

0

0

0

0

0

0

0

0

Not sensitized

18

Female

0

0

0

0

0

0

0

0

Not sensitized

19

Female

0

0

0

0

0

0

0

0

Not sensitized

20

Female

0

0

0

0

0

0

0

0

Not sensitized

The sensitization rate at 24 h and 48 h was 0%

No deaths occurred. No significant difference in body weight gain was observed between treated and control group.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified