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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation, other
Remarks:
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:
6 Aug - 30 Aug 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study with acceptable restrictions (analytical purity of test substance not specified, no positive control group)

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)
Version / remarks:
adopted in 1981
Deviations:
yes
Remarks:
analytical purity of test substance not specified, no positive control group
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
no data available

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
Details on test material:
- Name of test material (as cited in study report): Only trade name given, Fatty acids, C16-18, 2-ethylhexyl esters
- Physical state: colourless liquid
- Analytical purity: no data
- Batch number: 90068
- Storage: at room temperature

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: guinea pigs sustenance ref. 106 (U.A.R., Villemoisson-sur-Orge, France), ad libitum
- Water: tap water, ad libitum
- Acclimation period: for a minimal period of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12 / 12

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25% (intradermal induction, 50% (challenge)
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: 25% (intradermal induction, 50% (challenge) . 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:
25% (intradermal induction, 50% (challenge)
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: 25% (intradermal induction, 50% (challenge) . 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:
25% (intradermal induction, 50% (challenge)
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: 25% (intradermal induction, 50% (challenge) . 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:
25% (intradermal induction, 50% (challenge)
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: 25% (intradermal induction, 50% (challenge) . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

Any other information on results incl. tables

Table 1: 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 Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
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 induced with 25% substance solution and challenged with a 50% test substance solutionl. 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.