Vanillin

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14-JUN-1991 to 13-NOV-1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EU Method B.3 (Acute toxicity (dermal))

Deviations:

yes

Remarks:

variation of humidity beyond the norms

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Vanillin

EC Number:

204-465-2

EC Name:

Vanillin

Cas Number:

121-33-5

Molecular formula:

C8H8O3

IUPAC Name:

1-butoxypropan-2-ol

Test animals

Species:

rat

Strain:

Sprague-Dawley

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Sex: male/female
- Source: Iffa-Crédo (L'Arbresle, France)
- Age at study initiation: 5 - 8 weeks old
- Weight at study initiation: 204 - 271 g
- Fasting period before study:
- Housing: housed individually in polycarbonate cages (305 x 180 x 184 mm)
- Diet: complete pelleted rat-mouse maintenance diet, ad libitum
- Water: softened and filered mains drinking water, ad libitum
- Acclimation period: 7 days before the start of treatment

ENVIRONMENTAL CONDITIONS:
- Temperature: 20 - 24 °C
- Humidity: 43 - 85 %
- Air changes: at least 8 per hr
- Photoperiod: 12 hrs dark / 12 hrs light (artificial)

In-life dates: from 26-AUG-1991 to 09-SEP-1991

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

- Test material:
* Amount applied: 2000 mg/kg
* Concentration: 69.56 % (w/v)
* pH: 4.7
- Vehicle:
* Amount applied: data not available
* Purity: purified water

Duration of treatment / exposure:

24 hour(s)

Observation period:

14 days

Number of animals:

10

Details on study design:

- Test site:
* Area of exposure: data not available
* % coverage: approximately 10 %
* Type of wrap if used: perforrated adhesive band 10 cm wide, applied onto an elastic crepe bandage covering the entire shaved area

- Removal of test substance:
* Washing: yes, with lukewarm water
* Time after start of exposure: 24 hours

- Scoring system: according to EU guideline

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Remarks on result:

other: yellowish coloration

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: yellowish coloration

Irritant / corrosive response data:

The only effect noted was a yellowish colouration of the skin of all rats on days 2 to 15 of the study. No erythema or edema were noted during the observation period.

Other effects:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

GHS EU classification: not classified.

Executive summary:

In an acute dermal toxicity study (Lheritier, 1991), young adult Sprague-Dawley rats (5/sex) were dermally exposed to 2000 mg/kg bw of Cristallised Vanilline (purity unknown) in water for 24 hours to 10% body surface area. Test sites were covered with a semi-occlusive dressing for 24 hours. Animals then were observed for 14 days. Irritation was scored by the method of EU guideline.
 
In this study, Cristallised Vanilline is not a dermal irritant based on the absence of skin reaction. Only a yellowish colour was observed from days 2 to 14.