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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 21, 2014 - February 5, 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to OECD guidelines and GLP so therefore meets the criteria of Klimisch code 1.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guideline
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

Constituent 1
Chemical structure
Reference substance name:
Aminoguanidinium hydrogen carbonate
EC Number:
219-956-7
EC Name:
Aminoguanidinium hydrogen carbonate
Cas Number:
2582-30-1
Molecular formula:
CH6N4.CH2O3
IUPAC Name:
N-aminoguanidine; carbonic acid
Details on test material:
Name of test item: Aminoguanidinium hydrogen carbonate
CAS No.: 2582-30-1
Purity: 98.6 g / 100 g (based on acidimetric titration)
Storage Conditions: Room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Strain: Crl:WI(Han)
- Age at study initiation: males: 8 weeks, females:12 weeks
- Weight at study initiation: All animals were within 20% of the mean weight
- Housing: Rats were held individually in Makolon cages, type III
- Diet (e.g. ad libitum): Free access to VRF1 (P); SDS Special Diet Services
- Water (e.g. ad libitum): Water Free access to tap-water.
- Acclimation period: At least 5 days prior to start of treatment.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30 to 70 % relative
- Air changes (per hr): approximately 10 per hour
- Photoperiod (hrs dark / hrs light): 12 hour light / 12 hour dark cycle

IN-LIFE DATES: From: 21 January 2014 To: 5 February 2014

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Fur was clipped 24 hours before administration. The application area was 40 cm2.
Duration of exposure:
24 hours. The application site was covered with a semi-occlusive dressing. After removal of the dressing, the application site was washed with warm water.
Doses:
5000 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: On day of dosing and day 7 and 14 following dosing.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs observed each day
Statistics:
No mortality occurred. Use of statistics not indicated

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: No mortality during study.
Mortality:
Mortality did not occur in treated animals.
Clinical signs:
other: No systemic clinical signs were observed during clinical observation.
Gross pathology:
No macroscopic abnormalities were noted in the animals examined on the last day of observation

Any other information on results incl. tables

Table 2: Number of animals dead [and with evident toxicity] [and time range within which mortality occurred]

 

Dose
(mg/kg bw)

Conc.
in vehicle (%)*

Mortality (# dead/total)

Time range of deaths (hours)

Number with evident toxicity (#/total)

Male

Female

Combined

Male

Female

Combined

5000

 0/5

 0/5

0/10 

 

 0/5

 0/5

0/10

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No mortality has occurred at doses of 5000 mg/kg bw. The study has therefore been completed as a limit test, and the LD50 is considered to be more than 5000mg/kg.
Executive summary:

In an acute dermal toxicity study, groups of Winstar rats (5/sex) were dermally exposed to a single dose of 5000 mg/kg bw of Aminoguanidinium hydrogen carbonate which was covered by a semi-occlusive dressing for 24 hours. The animals were then observed for 14 days.

No mortality occurred and there were no systemic clinical signs of toxicity observed during clinical examination. Therefore the LD50 is considered to be > 5000 mg/kg.

This acute study is classified as reliable without restriction. It satisfies the guideline requirement for an acute dermal study in the rabbit.