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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited reporting, however study considered adequate for assessment.
Cross-reference
Reason / purpose:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978
Reference Type:
secondary source
Title:
Unnamed
Year:
2008

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Groups of rats were given a single oral dose of a C14-17 chlorinated paraffin (chlorinated to either 40 or 45%) and observed for up to 14 days.
GLP compliance:
no
Remarks:
Prior to GLP
Test type:
other: acute oral LD50 study according to Company's Methods manual
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Meflex DC024 and Meflex DC029
- Substance type: technical product
- Physical state: pale yellow liquid
- Impurities (identity and concentrations): 0.2% epoxy soya bean oil; 0.3% lubrizol LZ55A; 0.3% polyethylene glycol; 0.2% NonoxWSL
- Composition of test material, percentage of components: Meflex DC024; a C14-17 n-paraffin, chlorinated to 40%. Meflex DC029; a C14-17 n-paraffin, chlorinated to 45%
- Stability under test conditions: "good"
- Storage condition of test material: ambient temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Alderley Park SPF colony- Weight at study initiation: 150-250 g- Fasting period before study: no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
No data
Doses:
10 ml/kg bw
No. of animals per sex per dose:
Groups of 6 animals (sex not specified)
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days - Frequency of observations and weighing: no data- Necropsy of survivors performed: yes- Other examinations performed: clinical signs, body weight,
Statistics:
No data

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 10 mL/kg bw
Based on:
test mat.
Remarks on result:
other: No confidence limits given
Mortality:
No deaths reported for Meflex DC024 or Meflex DC029
Clinical signs:
Restricted to incontinence during the first 48 hours, although numbers of animals affected and with which specific test material not reported.
Body weight:
Body weight gain reported as normal.
Gross pathology:
No data
Other findings:
No data

Any other information on results incl. tables

No data was available on the effects of the individual materials on individual animals

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
No deaths or other severe adverse effects were seen in rats observed for 14 days following gavage administration of Meflex DC024 or Meflex DC029 (C14-17 chlorinated paraffins; 40 or 45% chlorination) as a single oral dose at 10 ml/kg bw . The oral LD50 is greater than 10 ml/kg bw.
Executive summary:

Groups of six albino rats were given a single dose of C14-17 chlorinated paraffins (Meflex DC024, 40% chlorinated or Meflex DC029, 45% chlorinated) by stomach tube at a dose level of 10 ml/kg bw. Animals were observed for 14 days after dosing for abnormal clinical signs. No mortalities were observed for either of the tested chlorinated paraffins, and body weight gains over the observation period were reported as "normal". The acute oral LD50 for both C14-17 chlorinated paraffins is greater than 10 ml/kg bw and therefore neither test material would be classified for acute oral toxicity under EU CLP or DSD regulations.