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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:
2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: pellets
Details on test material:
Batch-No.: 07111601

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
2,000 mg/kg
300 mg/kg
No. of animals per sex per dose:
Treated group (2000 mg/kg): 6 female rats
Treated group (300 mg/kg): 6 female rats
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Systematic examinations were carried out to identify any behavioural or toxic effects on the major physiological functions 14 days after administration of the test item. The animals were weighed on day D0 (just before administering the test item) then on D2, D7, and D14.
Weight changes were calculated and recorded.
- Necropsy of survivors performed: On D14, the animals were anaesthetised with sodium pentobarbital and administration continued to fatal levels.
- Other examinations performed: Macroscopic observations were entered on individual autopsy sheets. Only those organs likely to be modified in cases of acute toxicity were examined. Those presenting macroscopic anomalies can be removed and preserved in view to microscopic exanimations.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - < 2 000 mg/kg bw
Based on:
test mat.
Mortality:
It was noted the death of 4 treated rats treated at 2000 mg/kg b.w., 7, 8 and 24 hours after the test item administration.
No mortality occurred in the animals treated at 300 mg/kg b.w..
Clinical signs:
It was registered in the animals treated at 2000 mg/kg, 30 minutes after the test item administration, a decrease of the spontaneous activity (6/6) associated with a piloerection (4/6) and a decrease of the righting reflex (1/6) at the reading time 4 hours. The surviving animals recovered a normal activity the 2nd day of the test.
No clinical signs related to the administration of the test item at 300 mg/kg were observed.
Body weight:
It was noted a body weight decrease (-4%) on the surviving animals treated at 2000 mg/kg b.w., 48 hours after the test item administration. Then the body weight evolution of the animals remained normal throughout the study.
The body weight evolution of the animals treated at 300 mg/kg remained normal throughout the study.
Gross pathology:
The macroscopical examination of the animals treated at 2000 mg/kg which died during the test revealed the presence of black foci on the corpus and a decrease of vascularisation on the forestomach (4/4).
The macroscopical examination of the animals treated at 2000 mg/kg at the end of the study revealed a
white thickening layer at the level of the forestomach (2/2).
The macroscopical examination of the animals treated at 300 mg/kg at the end of the study did not reveal treatment-related changes.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
LD50>300 mg/kg bw
LD50<2,000 mg/kg bw
Executive summary:

In conclusion, the LD50 cut-off of the test item Sodium caprolactamate in caprolactam is 2000 mg/kg

body weight by oral route in the rat.

In accordance with the Globally Harmonized System (COM(2007)355 final), the test item needs to be

classified in category 4. The signal work “warning” and hazard statement H302 “Harmful if

swallowed” are required.