Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982-04-28 to 1982-05-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Protocol that complies with scientifically accepted methods, and is sufficiently detailed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Section 1500.3 – Federal Hazardous Substance Act Regulations – 16 CFR.
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no data reported

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
-Source: No data available.
-Age at study initiation: No data available.
-Weight at study initiation: average weight between 200~300 g.
-Fasting period before study: Feed (not water) was withheld overnight prior to dosing.
-Housing: the animals were housed and maintained in accordance with the Animal Welfare Act 9 CFR Part 3. 3~5 rats/cage by sex.
-Diet: Wayne Lab-Blox was provided ad libitum.
-Water: tap water was available ad libitum.
-Acclimation period: acclimated to the laboratory for an appropriate time prior to dosing.

ENVIRONMENTAL CONDITIONS
-Temperature: 70~72 °F
-Humidity: 40 % ~ 50 %
-Air changes: controlled environment, but no air change information provided.
-Photoperiod: 12 h light/dark cycle.

IN-LIFE DATES:
From: 03/02/1983
To: 04/13/1983

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: Not applicable.
- Amount of vehicle (if gavage): Not applicable.
- Justification for choice of vehicle: Not applicable.
- Lot/batch no. (if required): Not applicable.
- Purity: Not applicable.

MAXIMUM DOSE VOLUME APPLIED:
DOSAGE PREPARATION (if unusual): Not applicable.
CLASS METHOD (if applicable): Not applicable.
- Rationale for the selection of the starting dose: No data.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 /sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed frequently on the day of dosage and twice daily thereafter (morning and afternoon). Individual weights were recorded on the day of dosage, weekly thereafter and prior to sacrifice.
- Necropsy of survivors performed: gross necropsies were performed on all animals that either died during the 14 day observation period or on surviving animals that were sacrificed at the conclusion of the 14 day observation period.
Statistics:
No data available.

Results and discussion

Preliminary study:
Not applicable
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
Male: Number of animals: 5; Number of deaths: 1
Female: Number of animals: 5; Number of deaths: 0
Clinical signs:
All animals appeared ruffled up to 3 h after treatment; they appeared oily and dirty after 24h, but appeared normal thereafter. One male rat died on day 2 with the remaining animals exhibited a discharge around the eyes and nose. They appeared essentially recovered after 72 h and continued to appear normal throughout the remainder of the observation period. Gross pathologic examination revealed nothing remarkable.
Body weight:
All animals showed bodyweight gain.
Gross pathology:
No gross abnormalities were noted in all animals (either found dead during the study or in the animals necropsied at the conclusion of the study).

Any other information on results incl. tables

Table 1. Results

Dose Level (mg/kg)

5000

Sex

Male

Female

Average Body Weight (g)

Initial

269

228

7 d

341

257

14 d

372

280

Mortality (No. death/No. dosed)

1/5

0/5

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test article, when administered as received to male/female Sprague-Dawley rats, had an acute oral LD50 of greater than 5000 mg/kg bodyweight
Executive summary:

In an acute oral toxicity study, fasted Sprague-Dawley strain Albino rats (five male and five female) were given a single oral dose of undiluted test material at a dose level of   5000  mg/kg bw and observed for14 days.

All animals appeared ruffled up to 3 h after treatment; they appeared oily and dirty after 24h, but appeared normal thereafter. One male rat died on day 2 with the remaining animals exhibited a discharge around the eyes and nose. They appeared essentially recovered after 72 h and continued to appear normal throughout the remainder of the observation period. Gross pathologic examination revealed nothing remarkable.

The oral LD50 value of test material in rats of both sexes has been determined to be greater than 5000 mg/kg. And the substance was considered not toxic.