Semicarbazide hydrochloride

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Semicarbazide hydrochloride

EC Number:

209-247-0

EC Name:

Semicarbazide hydrochloride

Cas Number:

563-41-7

Molecular formula:

CH5N3O.ClH

IUPAC Name:

semicarbazide hydrochloride

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Chemring Nobel AS, 55507861
- Expiration date of the lot/batch: 28/04/2019
- Purity test date: 99,3%
Physical staate/Appearance : White solid

RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity:
- Specific activity:
- Locations of the label:
- Expiration date of radiochemical substance:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
- Stability under test conditions:
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item was moistened with distilled water.
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:

FORM AS APPLIED IN THE TEST (if different from that of starting material)

TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable)

OTHER SPECIFICS:

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Envigo RMS (UK), UK
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 12 weeks of age
- Weight at study initiation: the weight variation did not exceed +/-20% of the mean for each sex
- Fasting period before study: no
- Housing: in suspended solid floor polypropyene cages furnished with woodflakes
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70 % relative humidity
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Remarks:

distilled water

Details on dermal exposure:

TEST SITE
- Area of exposure: shorn skin of the back and the flanks
- % coverage: 10 % of the total body surface area
- Type of wrap if used:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): distilled water
- Time after start of exposure:24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Constant volume or concentration used: yes
- For solids, paste formed: yes 2000mg/kg bw

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:

Duration of exposure:

24 hours

Doses:

2000mg/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 : 30 minutes, 1, 2 and 4 hours after dosing and once daily for 14 days
After removal of the dressings and subsequently once daily for 14 days the test sites were examined for evidence of primary irritation and scored according to the scale presented in the study report.
- Frequency of body weights : prior to application of the test item in Day 0 and on Days 7 and 14
- Necropsy of survivors performed: yes, gross necropsy, consisting of an external examination and opening of the abdominal and thoracic cavities
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:- Duration of observation period following administration: 14 days (or other?)
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Preliminary study:

Initially 2 animals (1 male and 1 female) were given a single, 24-hour, semi-occluded dermal application of the test item to intact skin at a dose level of 2000 =mg/kg bw.
As no mortalities were noted a further group of aimals (4 males and 4 females) has been treated in the main test.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths

Clinical signs:

other: No signs of systemic toxicity were noted during the observation period

Gross pathology:

No abnormalities were noted at necropsy

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000mg/kg bw

Executive summary:

In a acute dermal toxicity study, performed according to the GLP and the OECD Guideline 402, groups of 5 male and 5 female rats were given a single, 24 -hour, semi-occluded dermal application of DNAN to intact skin at a dose level of 2000mg/kg bw.

There were no deaths, no signs of dermal irritation, no signs of systemic toxicity, all animals showed expected gains in body weight and no abnormalities wre noted at necropsy.

The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000mg/kg bw.