3-phenylbutyraldehyde

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

November - December 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study in compliance with guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

yes

Remarks:

(20 animals per treatment group is recommended in the current guideline)

GLP compliance:

yes

Type of study:

Buehler test

Test material

Test material information

Constituent 1

Reference substance name:

3-phenylbutyraldehyde

EC Number:

240-362-9

EC Name:

3-phenylbutyraldehyde

Cas Number:

16251-77-7

Molecular formula:

C10H12O

IUPAC Name:

3-phenylbutanal

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): ST 25C 88
- Physical state: clear colorless liquid

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: D. Hall, Darley Oaks, Burton-on-Trent, Staffordshire, England.
- Age at study initiation: no data available. Study cited that animals are young.
- Weight at study initiation: range of 407 to 498 g (mean of 455 g)
- Housing: Animals were housed in groups of ten in stainless steel cages fitted with mesh floors and of the approximate dimensions 85 x 57 x 25cm.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 45-68 %
- Air changes (per hr): no data available. Air conditioning was provided
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: experimental work was cited as taking place from 17-Nov-1988 to 23-Dec-1988.

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

other: No vehicle was used in the induction phase. Ethanol was used as the vehicle in the challenge phase. Ethanol was also used as the vehicle in the preliminary irritation screening study.

Induction 2

Concentration / amount:

- Irritation screening study: 0.5 mL of the following concentrations of test material: 12.5%, 25%, 50%, 100% v/v. Solvent was ethanol. (The preliminary irritation screening assay showed no irritation effects at concentrations of 12.5%, 25%, 50% or 100% of test substance, hence the induction phase of the study used the undiluted test material).
- Main study, induction phase: 0.5 mL of undiluted test material.
- Main study, challenge phase: 0.5 mL of undiluted test material (left flank) and 0.5 mL of 50 % v/v diluted test material in ethanol (right flank).

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

other: No vehicle was used in the induction phase. Ethanol was used as the vehicle in the challenge phase. Ethanol was also used as the vehicle in the preliminary irritation screening study.

Challenge 2

Concentration / amount:

- Irritation screening study: 0.5 mL of the following concentrations of test material: 12.5%, 25%, 50%, 100% v/v. Solvent was ethanol. (The preliminary irritation screening assay showed no irritation effects at concentrations of 12.5%, 25%, 50% or 100% of test substance, hence the induction phase of the study used the undiluted test material).
- Main study, induction phase: 0.5 mL of undiluted test material.
- Main study, challenge phase: 0.5 mL of undiluted test material (left flank) and 0.5 mL of 50 % v/v diluted test material in ethanol (right flank).

No. of animals per dose:

- Irritation screening study: 4 animals
- Main study, induction and challenge phase:
Test group: 10 animals
Control group: 10 animals

Details on study design:

IRRITATION SCREENING STUDY:
- No. of exposures: 1
- Exposure period: 6 hrs
- Test groups: 1 group of 4 animals
- Control group: none
- Site: flank (no details on whether left or right)
- Evaluation: 24 and 48 hrs
- Concentrations: 0.5 mL of the following concentrations of test material: 12.5%, 25%, 50%, 100% v/v. Solvent was ethanol.
- Application: using a 2 cm square of gauze, occluded. Test site was clipped free of fur one day prior to application of the test material.

MAIN STUDY
A. INDUCTION PHASE
- No. of exposures: 3
- Exposure period: 6 hrs
- Test groups: 1 group of 10 animals
- Control group: 1 group of 10 animals
- Site: left shoulder area
- Frequency of applications: application at day 1, day 8 and day 15
- Duration: 28 days
- Concentrations: 0.5 mL of undiluted test material
- Application: using a 2 cm square of gauze, occluded. Test site was clipped free of fur one day prior to application of the test material.

B. CHALLENGE PHASE
- No. of exposures: 1
- Day(s) of challenge: day 29
- Exposure period: 6 hrs
- Test groups: 1 group of 10 animals
- Control group: 1 group of 10 animals
- Site: left and right flank
- Concentrations: 0.5 mL of undiluted test material (left flank) and 0.5 mL of 50 % v/v diluted test material in ethanol (right flank)
- Application: using a 2 cm square of gauze, occluded. Test site was clipped free of fur one day prior to application of the test material.
- Evaluation (hr after challenge): 24 and 48 hrs after the application.

Challenge controls:

no data

Positive control substance(s):

no

Results and discussion

Positive control results:

not applicable

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

Undiluted and 50% test material

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: test group. Dose level: Undiluted and 50% test material . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

Undiluted and 50% test material

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: test group. Dose level: Undiluted and 50% test material . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

Any other information on results incl. tables

No response was exhibited by any animal of the test or control group following challenge with the undiluted test material and a 50% dilution of the test material in ethanol.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information under CLP REGULATION (EC) No 1272/2008 Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

Conclusions:

There was no evidence to suggest that the test material acts as a sensitiser in the guinea pig.

Executive summary:

A GLP-compliant study was conducted in guinea pigs to assess the skin sensitisation potential of the substance using the Buehler test. The study was conducted according to the OECD Testing Guideline No. 406. Following induction using the undiluted substance applied for 6 hours on each of days 1, 8, and 15 of the study, a challenge application of the undiluted (i.e., 100%) and diluted (50% in ethanol) substance was initiated on Day 28. Following scoring of the skin sites, it was observed that there were no responses in any of the animals at any of the test sites. Criteria for Buehler assay: a response of at least 15 % of the animals is considered positive and it means that at least one animal was observed to have a positive response in this study. Regarding irritation in the preliminary assay, concentrations of 12.5%, 25%, 50% and 100% of the substance did not elicit signs of irritation. Altogether, it was concluded that there was no evidence to indicate that the substance acts as a sensitiser in the guinea pig. Therefore, based on the results of this study, there is unlikely to be any risk of sensitisation occurring in man following repeated dermal exposure to the material.