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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1992
GLP compliance:
no
Type of study:
guinea pig maximisation test
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
Route:
intradermal
Vehicle:
paraffin oil
Concentration / amount:
0.1 ml 20% and 40%
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.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
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.

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

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

In cases where no data were available on the target substance, Benzene, C15 -16 -alkyl derivs., data were read across from a structurally related material (the test substance).

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A key study conducted in guinea pigs demonstrated that a read-across source substance for Benzene, C15-16-alkyl derivs. is not sensitizing to the skin.

The key study (Murmann 1983) examined the potential of the test substance to cause sensitization to skin. Groups of 20 female guinea pigs were exposed by a 0.1 mL intradermal injection of 20% and 40% a read-across source substance for Benzene, C15-16-alkyl derivs.. One week later, they were exposed dermally to a solution of 50% test substance and covered with an occlusive dressing. The first challenge was 14 days later, in which the animals were exposed to 20% test substance dermally. One week after that, 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 hours after the last challenge. The 48 hour reading was used to determined sensitization. No signs of dermal irritation were seen at this reading. The test substance is not sensitizing to skin.


Migrated from Short description of key information:
A key study conducted in guinea pigs demonstrated that a read-across source substance for Benzene, C15-16-alkyl derivs. is not sensitizing to the skin.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification