di-, tri- and tetrachlorotetradecane

Acute Toxicity: oral

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 in review, including no details as to whether study performed to test guidelines or GLP, however study considered adequate for assessment.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference 1

Reference Type:

publication

Title:

The toxicological effects of chlorinated paraffins in mammals

Author:

Birtley RDN, Conning DM, Daniel JW, Ferguson DM, Longstaff E and Swan AAB

Year:

1980

Bibliographic source:

Toxicol. Appl. Pharmacol. 54: 514-525

Reference 2

Reference Type:

secondary source

Title:

Unnamed

Year:

2008

Materials and methods

Principles of method if other than guideline:

Groups of at least 3 male and/or female rats were given a single oral dose of one of several C14-17 chlorinated paraffins (ranging from 51-60% chlorination) and observed for clinical signs for up to 14 days.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Alkanes, C14-17, chloro

EC Number:

287-477-0

EC Name:

Alkanes, C14-17, chloro

Cas Number:

85535-85-9

Molecular formula:

Substance is a range of chlorinated isomers of C14 to C17 paraffin

IUPAC Name:

Alkanes, C14-17, chloro

Details on test material:

- Name of test material (as cited in study report): C14-17 chlorinated paraffins (51-60% chlorination)
- Substance type: technical product
- Purity: no data
- Composition of test material, percentage of components: C14-17 n-paraffins (51-60% chlorination)
- Impurities: no details on presence/absence of a stabiliser

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: Animal Breeding Unit, Imperial Chemical Industries Ltd, Alderley Park, UK- Age at study initiation: not reported- Weight at study initiation: between 125 and 250 g- Fasting period before study: 16 hours- Housing: no data- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: As supplied or in eg olive oil

Details on oral exposure:

no data

Doses:

Not specified, but between 0.5 and 10 g/kg bw for all of the various chlorinated paraffins studied.

No. of animals per sex per dose:

At least three

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days- Frequency of observations and weighing: animals obseved "regularly" for abnormal clinical signs- Necropsy of survivors performed: yes- Other examinations performed: clinical signs, histopathology of certain organs considered to have been affected by treatment

Statistics:

Not reported

Results and discussion

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 4 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No confidence intervals given

Mortality:

No deaths observed

Clinical signs:

other: Clinical signs of toxicity were not mentioned in respect of the C14-17 chlorinated paraffins, being confined "mainly" to rats which received a high dose (4 g/kg bw or above) of the C10-13 chlorinated paraffins. They included piloerection, muscular incoord

Gross pathology:

The general comment was that hepatocellular vacuolation and occassional necrotic foci were seen in the liver and cloudy swelling of some inner cortical cells was seen in the kidney. These effects were mainly seen in the animals treated with the C10-13 chlorinated parafins, which showed signs of toxicity, and were not mentioned specifically for the C14-17 chlorinated paraffin-treated rats.

Other findings:

- Other observations: occasional inflamation of the gastric mucosa was observed following administration of "some chlorinated paraffins" (not further specified in review).

Any other information on results incl. tables

No data is presented on which specific chlorinated paraffin the effects were attributed, the dose levels at which the effects occurred, or on whether the test material contains added stabilizer (0.2% epoxidized vegetable oil). It is not possible to delineate the results of the work on SCCPs and MCCPs

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 given single unspecified doses of various C14-17 chlorinated paraffins (ranging from 51-60% chlorination) by stomach tube (from between 0.5 and 10 g/kg bw) and observed for 14 days. The acute oral LD50 was reported as greater than 4 g/kg bw

Executive summary:

Groups of 3 or more male and/or female Wistar rats were given single doses of various C14-17 chlorinated paraffins (ranging from 51-60% chlorination), including Cereclor S52 (a C14-17 chlorinated paraffin, with average chlorination of 52%) by stomach tube and observed for abnormal clinical signs for up to 14 days. At the end of this observation period, animals were autopsied and selected tissues/organs were examined histologically and microscopically. Dose levels varied from 0.5 to 10 g/kg bw, administered with or without a vehicle such as olive oil. A total of 8 experiments were carried out with the C14-17 chlorinated paraffins.

No mortalities were observed for any of the tested chlorinated paraffins, although various abnormalities were noted, including certain adverse clinical signs (piloerection, muscular incoordination and urinary/fecal incontinence) and histopathological changes (including hepatocellular vacuolation and focal necrosis in the liver and cloudy swelling of inner cortical cells in the kidneys). Birtley et al. (1980) comment that the toxic effects were slight and that the clinical signs generally disappeared within 7 days.

The limitations in reporting do not allow the observed effects to be attributed to any specific chlorinated paraffin sample or to ascertain at what dose level(s) the effects occurred. However, the acute oral LD50 in this study is reported as greater than 4 g/kg bw, and therefore C14-17 chlorinated paraffins would not be classified for acute oral toxicity under EU CLP or DSD regulations.