Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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

Constituent 1
Chemical structure
Reference substance name:
Vanillin
EC Number:
204-465-2
EC Name:
Vanillin
Cas Number:
121-33-5
Molecular formula:
C8H8O3
IUPAC Name:
4-hydroxy-3-methoxybenzaldehyde

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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: yellowish coloration
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.