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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14-JUN-1991 to 13-NOV-1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according a recognised guideline and under GLP conditions. Howerer, some deviations occurred and the purity of the test substance is unknown.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
variation of humidity beyond the norms
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
- 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: data not available
- 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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
* Test site:
- Area of exposure: data not available
- % coverage: apprimately 10 %
- Type of wrap if used: perforated 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

* Test material:
- Amount(s) applied: 2000 mg/kg bw
- Concentration: 69.56 % (w/v)
- For solids, paste formed: yes
- pH: 4.7

* Vehicle:
- Amount applied: data not available
- Purity: purified water
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- mortality and clinical signs: 15 minutes after administration, then at 1, 2 and 4 hours, and then daily for 14 days
- cutaneous lesions: daily from days 2 to 15
- weighing: immediately before application and at days 8 and 15
- Necropsy of survivors performed: yes
Statistics:
Not applicable

Results and discussion

Preliminary study:
2 groups each composed of 2 males and 2 females were treated under the same conditions as those employed in the main study, at the dose levels of 1000 and 2000 mg/kg. No deaths were seen at the dose level of 2000 mg/kg.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no mortality occurred
Clinical signs:
none
Body weight:
no effects
Gross pathology:
no effects
Other findings:
no cutaneous lesions were observed. Only a yellowish coloration was noted

Any other information on results incl. tables

Table 1: Number of animals dead during limit test

 

Dose
(mg/kg bw)

Mortality (# dead/total)

Time range of deaths (hours)

Male

Female

Combined

1000

0/2

0/2

0/4

/

2000

0/2

0/2

0/4

/

 

 

Table 2: Number of animals dead and with evident toxicity for principal study = limit test

 

Dose
(mg/kg bw)

Mortality (# dead/total)

Time range of deaths (hours)

Number with evident toxicity(#/total)

Male

Female

Combined

Male

Female

Combined

2000

0/5

0/5

0/10

/

0/5

0/5 

0/10

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

In an acute dermal toxicity study (Hazleton, 1991), groups of 5 -7 weeks old Sprague-Dawley rats (male / female) were dermally exposed to Vanilline for 24 hours to approximately 10% area of the body at doses of 2000  mg/kg bw.  Animals then were observed for 14 days.

 In the preliminary study, 2 males and 2 femalesper group were treated under the same conditions as those employed in the main study, at the dose levels of 1000 and 2000 mg/kg. No deaths were seen at all dose level tested of 2000 mg/kg.

Dermal LD50 Combined > 2000mg/kg bw. No clinical sign, except yellowish coloration of the skin and no mortality occurred at this dose.

     

According to classification criteria of EC regulation 1272/2008 Vanillin should not be classified for acute dermal toxicity based on the LD50 in male and female rats.