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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from peer reviewed journal

Data source

Reference
Reference Type:
publication
Title:
Determination of skin sensitization potential of test chemical
Author:
D.L.J. Opdyke
Year:
1973
Bibliographic source:
Food and Cosmetics Toxicology,1973

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as below
Principles of method if other than guideline:
Draize test
GLP compliance:
not specified
Type of study:
Draize test
Justification for non-LLNA method:
Not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzyl formate
EC Number:
203-214-4
EC Name:
Benzyl formate
Cas Number:
104-57-4
Molecular formula:
C8H8O2
IUPAC Name:
Benzyl formate
Test material form:
liquid
Details on test material:
Details on test material
-Name of the test material : benzyl formate
-Substance type : Organic
-Physical state : colorless liquid
- Molecular formula: C8H8O2
- Molecular weight : 136.14792 g/mol
- Smiles notation: C1=CC=C(C=C1)COC=O
- Purity : No data available
- Impurities (identity and concentrations): No data available

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
- Source: No data available

- Weight at study initiation: - 350gm

-Housing: wire mesh cages in pairs of the same sex
- Diet (e.g. ad libitum): - pelleted guinea pig diet, cabbage, hay
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
no data
Concentration / amount:
no data
Challengeopen allclose all
Route:
intradermal
Vehicle:
no data
Concentration / amount:
no data
No. of animals per dose:
ten
Details on study design:
Ten animals weighing about 350 g at the start of testing were used in each test which comprised either 4 males and 6 females or visa versa. For demonstration of sensitivity by challenge with the test substance the hair was shaved from both flanks with Oster animal clippers, size 40 blades, and the test substance injected intradermally into one flank and applied topically without occlusion to the other flank.

Experimental design:
For test material preliminary irritation tests were done in guinea pigs to determine concentrations suitable for sensitization testing. Guinea pigs were then treated by intradermal injection to induce sensitization and challenged 2 weeks later by both intradermal injection and topical application.
When there was no evidence of sensitization the induction and challenge procedures were repeated.
Challenge controls:
no data
Positive control substance(s):
not specified

Results and discussion

Positive control results:
no data

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1 ml
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
negative reactions
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 ml. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: negative reactions.

Applicant's summary and conclusion

Interpretation of results:
other: not sensitising
Conclusions:
Test chemical was considered to be non sensitizing to guinea pig skin by Draize test.
Test chemical was reported to be a non-sensitizer in Hartley strain albino guinea pigs exposed in a modified Draize procedure to 0.25% in the injection challenge and 20% in the application challenge; vehicles were not reported. Induction consisted of 10 animals given 0.1 ml intradermal injection at four different sites. Following a 2 week rest period, animals were challenged intradermally in one flank and topically in the opposite flank. Reactions were scored 24 h thereafter.
Executive summary:

Test chemical was considered to be non sensitizing to guinea pig skin by Draize test.

Test chemical was reported to be a non-sensitizer in Hartley strain albino guinea pigs exposed in a modified Draize procedure to 0.25% in the injection challenge and 20% in the application challenge; vehicles were not reported. Induction consisted of 10 animals given 0.1 ml intradermal injection at four different sites. Following a 2 week rest period, animals were challenged intradermally in one flank and topically in the opposite flank. Reactions were scored 24 h thereafter. There are no reports on the sensitization potential of the remaining perfume ingredients which caused sensitization in our guinea pig test. This suggests that they do not present a problem in use even though they appear to have some sensitization potential when stringently tested in guinea pig test.

The survey of sensitization in man by perfume ingredients which did not cause sensitization in guinea pig tests shows that nearly all the reports, based on patch tests, concern isolated cases. Patch test results show whether a person has or has not become sensitized to the test substance(s); they are an indication, not a proof, that the test substance is responsible for any clinical dermatitis. The evidence available indicates that perfume ingredients that are harmless to the very great majority of persons, do not sensitize guinea pigs by test procedures.