Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed GLP and OECD guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Nitrohydrochinondimethylether

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
average weight of the animals at the begin of the test: male 192.1 grams female: 181.7 grams
age of the animals at the begin of the test: male: 7 weeks, female: 9 weeks
source of the animals: Hoechst AG breeding colony
Temperature: 22 +-3°C; rel. humidity: 50 +-20% ; light for 12 hours per day
diet: rat standard diet (Altromin 1324) ad libitum
water: tap water ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Doses:
2000, 2500, 3150 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 220 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD50
Effect level:
2 120 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
2 330 mg/kg bw
Based on:
test mat.
Mortality:
2000 mg/kg bw male: 2/5, female: 1/5
2500 mg/kg bw male: 4/5, female: 3/5
3150 mg/kg bw male: 5/5, female: 5/5
Clinical signs:
Impaired consciousness, impaired locomotor system, reduced reflexes, irregular breathing, tremor, constricted palpebral fissures, bloody incrusted eyelids, margins and snouts. Surviving animals were free of symptoms after five days.
Body weight:
Body weight gain was not impaired.
Gross pathology:
In animals found dead pale spleen and liver, enhanced lobular pattern of the liver, blood in the urine and a yellow mucous mass filling the small intestines was observed. Surviving animals were free of macroscopic findings.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
LD50 male: 2120 mg/kg bw
LD50 female: 2330 mg/kg bw
Executive summary:

Acute toxicity of Nitrohydrochinondimethylether was tested according to OECD 401. Following this protocol doses of 2000, 2500, and 3150 mg/kg bw were administered by gavage to five male and five female rats per dose.

 

During the observation period of 14 days mortality occured at doses of 2000 (male: 2/5, female: 1/5), 2500 (male: 4/5, female: 3/5), and 3150 mg/kg bw (male: 5/5, female: 5/5). LD50 values of 2120 (male) and 2330 mg/kg bw (female) were calculated using probit analysis.

 

Animals showed impaired consciousness, impairment of locomotory system, reduced reflexes, irregular breathing, tremor, constricted palpebral fissures, bloody incrusted eyelids, margins and snouts. Surviving animals were free of symptoms after five days. In animals found dead pale spleen and liver, enhanced lobular pattern of the liver, blood in the urine and a yellow mucous mass filling the small intestines was observed. Surviving animals were free of macroscopic findings. Body weight gain was not impaired.