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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
7 December 1992 and 31 December 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Benzenamine, reaction products with aniline hydrochloride and nitrobenzene
EC Number:
309-912-6
EC Name:
Benzenamine, reaction products with aniline hydrochloride and nitrobenzene
Cas Number:
101357-15-7
Molecular formula:
This is a UVCB substance. See section 1.2 for individual components.
IUPAC Name:
Benzenamine, reaction products with aniline hydrochloride and nitrobenzene
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd., Manston, Kent, U.K.
- Age at study initiation: 5 - 8 weeks
- Weight at study initiation: males 142 - 161g, females 135 - 146g
- Fasting period before study: overnight fast immediately before dosing
- Housing: groups of five by sex in solid-floor polypropylene cages with sawdust bedding
- Diet and water: overnight fast before dosing and approximately two hours after dosing. Remainder of study ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22°C
- Humidity (%): 50 - 73%. (On one occasion the humidity and temperature were outside the limits specified in the protocol (19°C and 70% respectively). This was considered not to have affected the purpose or integrity of the study.
- Air changes (per hr): 15/hour
- Photoperiod (hrs dark / hrs light): 12 h dark/12h light


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
For the purpose of the study the test material was freshly prepared, as required, as a suspension at the appropriate concentration in arachis oil B.P. Homogeneity was assured by the use of a Silverson Homogeniser.
The concentration, homogeneity and stability of the test material preparations were not determined by analysis.
A preliminary range finding study was conducted using a single dose of 2000 mg/kg bodyweight (dose concentration: 200 mg/ml, dose volume: 10 ml/kg).
In the main study, all rats were given a single oral dose of test material, as a suspension in arachis oil B.P. at a dose level of 2000 mg/kg bodyweight (dose concentration: 200 mg/ml, dose volume: 10 ml/kg).
Doses:
Single oral dose by gavage of 2000 mg/kg suspension in arachis oil (range finding and main study). All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to its fasted bodyweight at the
time of dosing.
No. of animals per sex per dose:
Range finding study: one male, one female
Main study: five male, five female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 0.5, 1, 2 and 4 h after dosing and subsequently once daily for 14 days
- Frequency of observations and weighing: Individual bodyweights were recorded prior to dosing on Day 0 and on Days 7 and 14
- Necropsy of survivors performed: range finding study, no; main study, yes
- Other examinations performed: clinical signs, body weight
Statistics:
Data evaluations included the relationship, if any, between the animals' exposure to the test material and the incidence and severity of all abnormalities including behavioural and clinical observations, gross lesions, bodyweight changes, mortality and any other toxicological effects.
Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test material was made.

Results and discussion

Preliminary study:
In the rangefinding study, no deaths or signs of toxicity were noted. A main study was therefore conducted on five male and five female rats using the same dosage.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities.
Clinical signs:
No signs of systemic toxicity.
Black-coloured staining of the fur was noted in all animals during the study.
Body weight:
All animals showed expected gain in bodyweight during the study.
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to EU criteria.
Conclusions:
The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg
bodyweight.
Executive summary:

The test material was assessed in an acute oral toxicity study conducted according to OECD Test Method 401. Following a range-finding study, a group of ten fasted animals (five males and five females) was given a single oral dose of test material, as a suspension in arachis oil B.P. at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of dosing and then subjected to gross pathological examination.

There were no deaths. No signs of systemic toxicity were noted during the study. All animals showed expected gain in bodyweight during the study. No abnormalities were noted at necropsy.

The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was therefore found to be greater than 2000 mg/kg bodyweight.