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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 6th, 1991 - August 30th, 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
; lack of details on test substance; no data on reliability check
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
Fatty acids, C16-18, 2-ethylhexyl esters
EC Number:
292-951-5
EC Name:
Fatty acids, C16-18, 2-ethylhexyl esters
Cas Number:
91031-48-0
Molecular formula:
C24H48O2 to C26H52O2
IUPAC Name:
91031-48-0
Details on test material:
- Name of test material (as cited in study report): Fatty acids, C16-18, 2-ethylhexyl esters
- Physical state: colourless liquid
- Batch number: 90068
- Storage: at room temperature
- No further details given.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Lebeau breeding centre, Gambais, France
- Age at study initiation: approx. 5 weeks
- Weight at study initiation: male mean 436 g, female mean 423 g
- Housing: individual housing in polycarbonate cages
- Diet (e.g. ad libitum): ad libitum (guinea pigs sustenance ref. 106 (U.A.R., France)
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5 days

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:
paraffin oil
Concentration / amount:
Induction: three pairs of intradermal injection (One of each pair was injected on each side of the midline and from cranial (1) to Caudal (3)
1. 1:1 mixture of Freuds´complete adjuvant with 0.9% sodium chloride
2. Test substance (25%) in paraffin oil
3. 1:1 mixture of the undiluted test substance with Freuds´complete adjuvant and 0.9% sodium chloride
The epidermal induction was done with 100% test substance 24 h after a local irritation with sodium lauryl sulphate in vaseline

Challenge: 50% test substance in paraffin oil
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
Induction: three pairs of intradermal injection (One of each pair was injected on each side of the midline and from cranial (1) to Caudal (3)
1. 1:1 mixture of Freuds´complete adjuvant with 0.9% sodium chloride
2. Test substance (25%) in paraffin oil
3. 1:1 mixture of the undiluted test substance with Freuds´complete adjuvant and 0.9% sodium chloride
The epidermal induction was done with 100% test substance 24 h after a local irritation with sodium lauryl sulphate in vaseline

Challenge: 50% test substance in paraffin oil
No. of animals per dose:
20
Details on study design:
RANGE FINDING TESTS:
Based on the results of a preliminary study a 25% dilution of the test substance in paraffin oil was used for intradermal induction and the undiluted (100%) substance was used for the epidermal induction exposure. The undiluted test substance was found to be slightly irritating upon dermal application.
A 50% test substance concentration was selected for the challenge phase as the maximum non-irritant dose upon dermal exposure for 24 h under occlusive dressing.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: Intradermal induction on day 1. On day 7 a local irritation was induced using 0.5 mL of a 10 % sodium laurylsulphate in vaseline. On day 8 a epidermal induction was performed with 0.5 mL vehicle or 0.5 mL test substance. The dermal applications were held in place for 48 hours under occlusive dressing.
- Test groups: 20 animals, TS
- Control group: 10 animals treated with vehicle only
- Site: the scapular region of both sides
- Concentrations: 0.1 mL of 25% dilution of the test substance in paraffin oil was used for intradermal induction and 0.5 mL of the undiluted (100%) test substance was used for epidermal induction
- Duration: 10 days

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 12 days after the last induction treatment
- Exposure period: 24 h under occlusive dressing
- Test groups: 20 animals, TS
- Control group: 10, treated analogous to the test groups
- Site: the right flank was treated with the test substance; the left flank was treated with vehicle.
- Concentrations: 0.5 mL of a 50% solution in paraffin oil
- Evaluation (hr after challenge):24 and 48 h after removal of the dressing
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50 %
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: 50 %. 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:
50 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50 %
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: 50 %. 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:
50 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

Any other information on results incl. tables

Challenge readings

 

Group

Sex

Animals

24 h scoring period

48 h scoring period

Erythema

Edema

Erythema

Edema

LF

RF

LF

RF

LF

RF

LF

RF

Control

Males

1

0

0

0

0

0

0

0

0

2

0

0

0

0

0

0

0

0

3

0

0

0

0

0

0

0

0

4

0

0

0

0

0

0

0

0

5

0

0

0

0

0

0

0

0

Females

16

0

0

0

0

0

0

0

0

17

0

0

0

0

0

0

0

0

18

0

0

0

0

0

0

0

0

19

0

0

0

0

0

0

0

0

20

0

0

0

0

0

0

0

0

Treated

Males

6

0

0

0

0

0

0

0

0

7

0

0

0

0

0

0

0

0

8

0

0

0

0

0

0

0

0

9

0

0

0

0

0

0

0

0

10

0

0

0

0

0

0

0

0

11

0

0

0

0

0

0

0

0

12

0

0

0

0

0

0

0

0

13

0

0

0

0

0

0

0

0

14

0

0

0

0

0

0

0

0

15

0

0

0

0

0

0

0

0

Females

21

0

0

0

0

0

0

0

0

22

0

0

0

0

0

0

0

0

23

0

0

0

0

0

0

0

0

24

0

0

0

0

0

0

0

0

25

0

0

0

0

0

0

0

0

26

0

0

0

0

0

0

0

0

27

0

0

0

0

0

0

0

0

28

0

0

0

0

0

0

0

0

29

0

0

0

0

0

0

0

0

30

0

0

0

0

0

0

0

0

No deaths occured. No significant differences in the gain of body weight was observed between treatment and control group.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Under the given conditions the test substance was not sensitising to guinea pig skin.
Executive summary:

A Guinea pig maximization test was performed according to OECD Guideline 406. 20 test and 10 control animals (Dunkin-Hartley guinea pigs) were challenged with a 50 % test substance solution in paraffin oil. 24 and 48 hours after termination of challenge exposure skin readings revealed no indications for a skin sensitising potential of Fatty acids, C16-18, 2-ethylhexyl esters.

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