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EC number: 202-713-4 | CAS number: 98-92-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
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- Endpoint summary
- Stability
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- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Genetic toxicity
- Carcinogenicity
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- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data

Acute Toxicity: dermal
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:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Nicotinamide
- EC Number:
- 202-713-4
- EC Name:
- Nicotinamide
- Cas Number:
- 98-92-0
- Molecular formula:
- C6H6N2O
- IUPAC Name:
- nicotinamide
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material: Nicotinamide
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: White Russian (albino)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Males 14 - 16 months; Females 9 - 15 months
- Weight at study initiation: Males 2.38 - 2.95 kg; Females 2.48 - 2.93 kg
- Fasting period before study: 16 hours before treatment
- Housing: Stainless steel cages with grating floor, type ASTA, size: 48.5x40x36.5 cm (LxBxH), supplied by ASTA Pharma AG, 0-4800 Bielefeld, Germany
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: The animals were kept at least 5 days under test conditions before substance application after hair clipping. Veterinary supervision of the animals was done before start of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 - 22.5
- Humidity (%): 40 - 70 for a short period down to 35 %; this deviation was without any influence on the results of the study
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 6 a.m. to 6 p.m. artificial lighting, 6 p.m. - 6 a.m. natural light-dark-rhythm
IN-LIFE DATES:
- From: 14 Aug. 1990
- To: 29 Aug. 1990
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Shorn skin between shoulder and sacral region
- % coverage: 100 %
- Type of wrap if used: Occlusive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washing with tapwater
- Time after start of exposure: 24 hours - Duration of exposure:
- 24 hours
- Doses:
- Males 2000 mg/kg bw; Females 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 Males; 5 Females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were continuously observed for the first 4 to 6 hours after application and then once daily. The nature of the toxicity as well as the onset, the intensity, and the duration of the signs were recorded. Mortality was checked twice daily (a.m. and p.m.), on Saturdays, Sundays, on national and business holidays only once daily. The body weights were recorded at the beginning and also 7 and 14 days after application.
- Necropsy of survivors performed: A gross necropsy was performed on all animals. Macroscopical examination included external appearance, body orifices, body cavities (thoracic and abdominal), and their contents. - Statistics:
- Not applicable.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: The only sign of toxicity was a slight reddening of the application site detected immediately after removal of the patches. The finding was present in some animals up to the end of the observation period. Clinical symptoms are shown in table 1.
- Gross pathology:
- At necropsy no abnormal findings, except the a.m. slight reddening at the application site, were recorded.
Any other information on results incl. tables
Table 1: Male animal clinical symptoms
Dose | Symptoms | No. Animals |
2000 mg/kg bw | Slight reddening of the application site | 5/5 |
Table 2: Female animals clinical symptoms
Dose | Symptoms | No. Animals |
2000 mg/kg bw | Slight reddening of the application site | 5/5 |
Table 3: Male and female body weights
Dose (mg/kg bw) | Dermal Animal No. | Day 0 | Day 7 | Day 14 |
Male Animals |
Body weights (kg) | |||
2000 | 2203 | 2.44 | 2.45 | 2.45 |
2215 | 2.56 | 2.56 | 2.56 | |
2205 | 2.38 | 2.34 | 2.34 | |
2217 | 2.47 | 2.47 | 2.47 | |
2263 | 2.95 | 2.89 | 2.89 | |
Female Animals | ||||
2000 | 2286 | 2.48 | 2.5 | 2.5 |
2294 | 2.49 | 2.47 | 2.47 | |
2288 | 2.86 | 2.84 | 2.89 | |
2290 | 2.54 | 2.55 | 2.51 | |
2238 | 2.93 | 2.94 | 2.96 |
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Nicotinamide was tested for acute toxicity after single dermal application to rabbits. The LD50 values for male as well as female rabbits were above 2000 mg/kg bw (limit test).
- Executive summary:
A study according to EU Method B.3 and OECD Guideline 402 (Acute Dermal Toxicity) was carried out. Nicotinamide was tested for acute toxicity after single dermal application to rabbits. The test substance, available as a white, crystalline powder, was moistened with water and placed on the shorn dorsal skin of 5 male and 5 female animals under occlusive conditions for 24 hours. The dose was 2000 mg/kg bw (limit concentration). The only sign of toxicity was a slight reddening of the application site detected immediately after removal of the patches. The finding was present in some animals up to the end of the observation period. Deaths did not occur. At necropsy no abnormal findings, except the slight reddening at the application site, were recorded. The LD 50 values for male as well as female rabbits were above 2000 mg/kg bw (limit test). Nicotinamide was considered practically non-toxic.
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