Vanillin

Acute Toxicity: dermal

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

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

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

Sex:

male/female

Details on test animals or test system 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:

other: none

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:

GHS criteria not met

Conclusions:

The substance is not classified since no mortality occured at the dose level of 2000 mg/kg/day.

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 females per 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.