Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979-06-06 to 1979-02-21
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Good quality, NTP study, comparable to guidelines

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986
Reference Type:
secondary source
Title:
Unnamed
Year:
2000

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
body weights not reported
GLP compliance:
no
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): C12 chlorinated paraffins (60% chlorination)
- Substance type: technical product
- Physical state: liquid
- Analytical purity: no data
- Impurities (identity and concentrations): no stabiliser, 6ppm hydrochloric acid
- Composition: mixture of C10 to C12 chlorinated n-paraffins with an average molecular weight of 415 and chlorine content of 60%.
- Purity test date: 1980-01-25
- Lot/batch No.: R-201-198
- Expiration date of the lot/batch: no data
- Stability under test conditions: stable for 2 weeks at 25oC
- Storage condition of test material: -20oC

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Industries, Indianapolis USA
- Age at study initiation: 8 weeks
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing: 5/polycarbonate cage
- Diet (e.g. ad libitum): Wayne Lab Blox pellets; ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±1
- Humidity (%): 30-50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light):12/12

IN-LIFE DATES: From: 1979-06-06 To:1979-06-21

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
gavage dose volume - 10 ml/kg bw
Doses:
816, 1632, 3400, 6800 and 13,600 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: observed 2x daily; body weights not reported
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs
Statistics:
none

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 13 600 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
All animals were inactive and ataxic after dosing.
Diarrhoea was observed in all groups of males and all but the lowest dose of females for 2-6 days after dosing.
These effects appear to be related to the large volumes of gavage material rather than chemical toxicity.
Body weight:
not recorded
Gross pathology:
no data
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No deaths were seen in groups of 5 male and 5 female rats given a single gavage dose of a C12 chlorinated paraffin (60% chlorinated) of up to 13.6 g/kg bw .
Executive summary:

In a good quality NTP study, groups of 5 male and 5 female F344/N rats were given single doses of a C12 chlorinated paraffin (60% chlorination) by stomach tube and observed for abnormal clinical signs twice per day for up to 15 days. The chlorinated paraffin was administered in corn oil at dose levels of 816, 1632, 3400, 6800 and 13,600 mg/kg bw.

No deaths were observed at any dose during the study period. All animals were inactive and ataxic after dosing. Diahrroea was seen in all males and all but the lowest dose females lasting between 2 and 6 days.

According to EU CLP and DSD regulations, this C12 chlorinated paraffin would not be classified as acutely toxic by the oral route.