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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
RCC AG
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Nicotinic acid
EC Number:
200-441-0
EC Name:
Nicotinic acid
Cas Number:
59-67-6
Molecular formula:
C6H5NO2
IUPAC Name:
nicotinic acid
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 or test system 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:
other: No clinical signs observed during the observation period.
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.