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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1986/10/01-1986/11/01
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an EU test method and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): NACOL 20

- Physical state: solid plates (pulverized by grinding)

- Lot/batch No.: 4601

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: Lippische Verschs tierzucht HAGEMANN GmbH&Co, D-4923 Extertal 1

- Age at study initiation: 42-50 days

- Weight at study initiation: 156-168g

- Housing: Animals were individually housed in MAKROLON cages

- Diet: Artificial diet for rats ALTROMIN 1324,ad libitum, but discontinued 15-16 hours before administration of dose.

- Water: tap water (ad libitum)




ENVIRONMENTAL CONDITIONS

- Temperature (°C): 21C (+/- 1C)

- Humidity (%): 55% (+/- 5C)

- Photoperiod (hrs dark / hrs light): 12h/12h


IN-LIFE DATES: Not stated.

Administration / exposure

Route of administration:
other: stomach tube
Vehicle:
other: 0.8% hydroxypropyl-methylcellulose gel
Details on oral exposure:
VEHICLE

- vehicle: 0.8% hydroxypropyl-methycellulose gel

- Amount of vehicle (if gavage): 8250 and 1000 mg/kg b.w NACOL 20

Doses:
8250 and 10000 mg/kg
No. of animals per sex per dose:
5 male and 5 female animals were tested for each dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Animals were observed during the 14 day period. The study does not specify how frequently.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: All animals were dissected and inspected macroscopically.
Statistics:
No statistical analysis was employed.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Mortality:
All animals survived the 14 day observation period.
Clinical signs:
No clinical signs of toxicity. There was no adverse effect on food intake.
Body weight:
There was no effect on bodyweight gain.
Gross pathology:
Necropsy findings were unremarkable.
Other findings:
No sex specific differences were apparent and no potential target organs were identified.

Any other information on results incl. tables

No toxic signs in any animals at any dose levels.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The rat oral LD50 is >10g/kg. At this dose level there was no evidence of toxicity in any of the parameters monitored. Reported in Iuclid 2000.