Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
RCC AG
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material: Nicotinic acid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: males: 7 week s; females: 9 weeks
- Weight at study initiation: males: 208 - 226 g; females: 170 - 191 g
- Fasting period before study: None.
- Housing:Macrolon cages Type 2, with wire mesh lids
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: 1 week under test conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 °C
- Humidity (%): 55 +/- 10
- Photoperiod: 12 hours/day

IN-LIFE DATES: From: 10 Aug. 1983 To: 24 Aug. 1983

Administration / exposure

Type of coverage:
occlusive
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
2 %
Details on dermal exposure:
TEST SITE
- Area of exposure: 20 cm2
- % coverage: 100
- Type of wrap if used: Occlusive dressing which was fixed by an adhesive elastic bandage wrapped around the trunk

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The skin was cleaned with lukewarm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 ml
- Concentration (if solution): 2000 mg/kg bw
- Constant volume or concentration used: Yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 4 ml
Duration of exposure:
Single exposure of 24 h.
Doses:
2000 mg/kg bw (limit test)
No. of animals per sex per dose:
5 male/5 female
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality: Five times during the first day, and daily thereafter.
Body weights:Body weights were recorded at the day of administration and days 8 and 15 of test.
Symptoms: Five times at day 1, and daily for the nature, onset, severity and duration of all gross or visible toxic or pharmacologic effects and time of death.
- Necropsy of survivors performed: Yes
Statistics:
The LOGIT Model could not be applied to the observed rates of death. The LD50 was estimated without use of a statistical model.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed during the observation period.
Clinical signs:
No clinical signs observed during the observation period.
Body weight:
Males 2000 mg/kg bw
day1 - 218 g +/- 7
day 8 - 249 g +/- 9
day 15 - 275 g +/- 8
Females 2000 mg/kg bw
day1 - 182 g +/- 8
day 8 - 190 g +/- 13
day 15 - 204 g +/- 19

Gross pathology:
No treatment related effects observed.
Other findings:
None.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute dermal toxicity study with rats (5 male/5 female Wistar) a single dose of 2000 mg/kg bw (occlusive) was administered. Following a 24 h exposure period and washing of exposed skin, animals were observed for 14 days. The LD0 obtained for males/females was 2000 mg/kg bw. The LD50 for males/females was > 2000 mg/kg bw. The test item was considered practically non-toxic.
Executive summary:

A study according to OECD Guideline 402 (Acute dermal toxicity) was carried out. Groups of rats (5 male/5 female Wistar) were administered a single dose of 2000 mg/kg bw (occlusive). Following a 24 h exposure period and washing of exposed skin, animals were observed for 14 days. The LD0 obtained for males/females was 2000 mg/kg bw. The LD50 for males/females was > 2000 mg/kg bw. The test item was considered practically non-toxic.