Pentyl formate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation

Remarks:

in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data is from peer reviewed journal.

Data source

Reference

Reference Type:

publication

Title:

THE SENSITIZATION POTENTIAL OF SOME PERFUME INGREDIENTS TESTED USING A MODIFIED DRAIZE PROCEDURE

Author:

D.W. SHARP

Year:

1978

Bibliographic source:

Toxicology, 9 (1978) 261-271

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Skin sensitization study of 3,7-dimethylocta-2,6-dien-1-yl formate (CAS No: 105-86-2) was conducted in 10 guinea pigs to determine its sensitization potential.

GLP compliance:

not specified

Type of study:

other: Modified DraizeTechnique

Test material

Test material information

Constituent 1

Reference substance name:

Geranyl formate

EC Number:

203-339-4

EC Name:

Geranyl formate

Cas Number:

105-86-2

Molecular formula:

C11H18O2

IUPAC Name:

3,7-dimethylocta-2,6-dien-1-yl formate

Test material form:

liquid

Details on test material:

Name of test material (as cited in study report):Geranyl formate
Molecular formula: C11H18O2
Molecular weight: 182.261 g/mol
Smiles: C(\CC\C=C(\C)C)(=C\COC=O)C
Substance type: Organic
Physical State: Liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): Geranyl formate
- Molecular formula: C11H18O2
- Molecular weight: 182.261 g/mol
- Substance type: Organic
- Physical state: Liquid
-Smiles: C(\CC\C=C(\C)C)(=C\COC=O)C
-InChI: 1S/C11H18O2/c1-10(2)5-4-6-11(3)7-8-13-9-12/h5,7,9H,4,6,8H2,1-3H3/b11-7+

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

male/female

Details on test animals and environmental conditions:

Details on test animal
TEST ANIMALS
- Source: N/A
- Age at study initiation: N/A
- Weight at study initiation: 350 g
- Fasting period before study: N/A
- 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): water ad libitum.
- Acclimation period:N/A

ENVIRONMENTAL CONDITIONS
- Temperature (°C): N/A
- Humidity (%): N/A
- Air changes (per hr): N/A
- Photoperiod (hrs dark / hrs light): N/A

IN-LIFE DATES: From: To: N/A

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal

Vehicle:

other: Yes suitable vehicle was used. (No detailed information )

Concentration / amount:

Induction concentration: 0.1 mL at 2.5 X 0.1(ICC) : 10 guinea pigs

Day(s)/duration:

24 hrs

Adequacy of induction:

not specified

Challenge

Route:

other: Intradermal and Epicutaneous, non occlusive

Vehicle:

other: Yes suitable vehicle was used. (No detailed information )

Concentration / amount:

Challenge concentration: 0.1 mL at 0.1 (ICC) and 20 (ACC): 10 guinea pigs
Rechallenge concentration: 0.1 mL at 0.1(ICC) and 20 (ACC): 10 guinea pigs

Day(s)/duration:

24 hrs

No. of animals per dose:

10 guinea pigs (6 male, 4 females or vice versa)

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE: Intradermal
- No. of exposures:4
- Exposure period: No Data Available
- Test groups:10 guinea pigs
- Control group: No Data Available
- Site: 4 sites, 2 auxillary and 2 inguinal lymph nodes
- Frequency of applications:1
- Duration: No Data Available
- Concentrations: 0.1 mL at 2.5 X 0.1 (ICC)

B. CHALLENGE EXPOSURE: Intradermal and Epicutaneous
- No. of exposures:1
- Day(s) of challenge: Fourteen days later, challenge test was performed
- Exposure period:24 hours
- Test groups:10guinea pigs
- Control group: No Data Available
- Site: onto the shaved flank in a small circular area
- Concentrations: 0.1 mL at 0.1 (ICC) and 20 (ACC).
- Evaluation (hr after challenge):24 hours

C. RECHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge:7 Days Later , rechalleange test was performed.
- Exposure period: No Data Available
- Test groups:10 animal
- Control group: 4 animal (same sex)
- Site: Intradermally and topically on opposite flanks
- Concentrations: 0.1 mL at 0.1 (ICC) and 20 (ACC).
- Evaluation (hr after challenge): No Data Available

Challenge controls:

4 animal (same sex):Rechallenge Test

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

Induction challenge concentration was found to be 0.1%

Total no. in group:

10

Clinical observations:

erythema and oedema.

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: Induction challenge concentration was found to be 0.1%. Total no. in groups: 10.0. Clinical observations: erythema and oedema..

Results 2

Reading:

2nd reading

Hours after challenge:

24

Group:

test chemical

Dose level:

Application challenge concentration was found to be 30%

Total no. in group:

10

Clinical observations:

erythema and oedema

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: Application challenge concentration was found to be 30%. Total no. in groups: 10.0. Clinical observations: erythema and oedema.

Any other information on results incl. tables

Each injection reaction was given a total score based on size (2 largest diameters), erythema and oedema.

Individual reactions were considered positive when their total score was significantly greater than the average total score for control reactions. Application reactions were scored on a 0 to +++ scale.

Applicant's summary and conclusion

Interpretation of results:

other: not sensitising

Conclusions:

The test material 3,7-dimethylocta-2,6-dien-1-yl formate (CAS No: 105-86-2) was considered to be non sensitizing on skin of guinea pigs according to modified Draize sensitization test.

Executive summary:

The skin sensitization study of 3,7-dimethylocta-2,6-dien-1-yl formate (CAS No: 105-86-2)was carried out in 10 Inbred Hartley strain albino the guinea pigs of to determine its irritation potential according modified Draize sensitization test.

 

For each test material preliminary irritation tests were done in guinea pigs to determine concentrations suitable for sensitization testing [injection challenge concentration(ICC) and application challenge concentration(ACC) ]

 

In the induction phase,the total dose was administered on one occasion as 4 intradermal injections, each 2.5 times the ICC (2.5X 0.1). Fourteen days later each animal was challenged intradermally in one flank and topically in the other with 0.1 ml aliquots of test substance at the respective ICC and ACC (0.1 and 20 respectively). Twenty-four hours later the reactions were observed.

 

In the absence of sensitization reactions at first challenge the induction and challenge procedures were repeated, andapparent sensitization reactions confirmed 7 days later by a second challenge with controls included.

 

Based upon the second challenge, it can be concluded that the test3,7-dimethylocta-2,6-dien-1-yl formate (CAS No: 105-86-2) was considered to be not sensitizing to Hartley guinea pigs as no skin reactions were observed.