Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Oct. 4, 1983-Nov. 6, 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well-documented study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1992
GLP compliance:
no
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: albino
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: F. Winkelmann
- Weight at study initiation: 319 g
- Housing: 1-5 animals in Makrolon type IV cages, idenitified by marking fur with dye
- Diet (e.g. ad libitum): G4 Alleindiat fur Meerschweinchen, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 4-8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-1 degree C
- Humidity (%): 60 +/- 5%
- Air changes (per hr): 15 per hr
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark


IN-LIFE DATES: From: Oct. 4, 1983 To: Nov. 6, 1983

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
paraffin oil
Concentration / amount:
0.1 ml 20% and 40%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
0.1 ml 20% and 40%
No. of animals per dose:
20 animals total
Details on study design:
In the induction phase, test guinea pigs received three pairs of intradermal injections simultaneously. The paired injections were, (1) 0.1 ml Freunds complete adjuvant (FCA), (2) 0.1 ml 20% test substance in paraffin oil, (3) 0.1 ml 40% test substance in FCA. One week later, 2 X 4 cm filter papers soaked with 50% test substance in paraffin oil were applied to the same area of the shoulders and then held in place with occlusive dressing for 48 hours. This application was followed by topical challenge about 14 days later in which the left flanks of test animals were exposed to 2 X 4 cm filter papers soaked with 20% substance in paraffin oil, held in place with occlusive wrapping. A second topical challenge was also performed about one week later, in which the right flanks of the test animals were exposed to 2 X 2 cm filter paper strips soaked with 5% and 10% test substance in paraffin oil, held in place for 24 hours with an occlusive wrapping. Observations of skin reactions indicative of irritation or sensitization at each challenge were conducted at 24, 48 and 72 hours following the removal of occlusive wrappings.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
5, 10, and 20% test substance
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: 5, 10, and 20% test substance. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 20.0.

Any other information on results incl. tables

Skin sensitization results at 48 hrs

Animal

20%

Left flank

20%

Left flank

5% Right flank back

10% Right flank front

5% Right flank front

10% Right flank back

1

0

0

0

0

0

0            

2

1*

1*

0*

0 (F)

0

0

3

1

0

0*

0* (O)

0

0

4

0

0

0

0

0

0

5

1*

0

0

0

0

0

6

0

0

0

0

0

0*

7

1

0

0

0*

0

0

8

0*

1*

0*

0*

0*

0*

9

0

0*

0

0

0

0

10

0

1*

0

0

0

0

11

0

0

0

0

0 (C)

0 (C)

12

1

1*

0

0

0*

0*

13

1

1

0

0

0*

0*

14

1*

1*

0

0*

0*

0*

15

0

0

0

0

0

0

16

1

1*

0

0

0

0

17

1*

1*

0*

0

0

0

18

1

1

0

0

0

0

19

1*

1*

0

0

0

0

20

0

0

0

0

0

0*

* - Dryness

C - Scratches

F - Redness

O – Hardening

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The test substance is not sensitizing to skin.
Executive summary:

This study examined the potential of the test substance to cause sensitization to skin. Groups of 20 female guinea pigs were exposed by injection to 20 and 40% test substance. One week later, they were exposed dermally to a solution of 50% test substance. The first challenge was 14 days later, and the animals were exposed to 20% test substance dermally. One week later, a second challenge was done, in which the animals were exposed to 5 and 10% test substance dermally. Animals were scored for skin irritation at 24, 48, and 72 hrs after the last challenge. The 48 hr reading was used to determine sensitization. No signs of dermal irritation were seen at this reading. The test substance in not sensitizing to skin.