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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Cited in final RAR on SCCPs (EU 2000); considered adequate for assessment, on related material

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974
Reference Type:
secondary source
Title:
Unnamed
Year:
2000

Materials and methods

Principles of method if other than guideline:
Acute toxicity following single inhalation exposure to a C10-13 chlorinated paraffin (50% chlorination) in rats
GLP compliance:
no
Remarks:
Prior to GLP
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Cereclor 50HS
- Substance type: technical product
- Physical state: no data
- Analytical purity: no data
- Impurities (identity and concentrations): no data on presence/absence of stabiliser
- Composition of test material, percentage of components: short chain chlorinated paraffin, 50% chlorinated (specific carbon chain length not identified, but C10-13 according to IPCS, 1996)

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no data

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
Maximum possible concentration at 150oC
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
1 h
Concentrations:
>48.17 g/m3
No. of animals per sex per dose:
no data
Control animals:
not specified
Details on study design:
no data
Statistics:
no data

Results and discussion

Preliminary study:
no data
Effect levels
Sex:
not specified
Dose descriptor:
LC50
Effect level:
> 48 170 mg/m³ air (nominal)
Based on:
test mat.
Exp. duration:
1 h
Remarks on result:
other: Cereclor 50HS; no confidence limits given
Mortality:
None reported
Clinical signs:
"Slight eye and nose irritation" reported in animals exposed for 1 hour to Cereclor 50HS vapour. Recovery occurred "soon" after exposure and remained normal throughout the [unspecified] observation period.
Body weight:
No data
Gross pathology:
No data
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
No deaths and only mild signs of eye and nose irritation were seen in rats exposed to the "vapour" of Cereclor 50HS, a short-chain chlorinated paraffin (50% chlorinated) at a concentration of 48.17 g/m3 for 1 h. The acute inhalation LC50 value is therefore greater than 48.17 g/m3 (48.17 mg/L).
Executive summary:

Cereclor 50 HS (a short-chain chlorinated paraffin, chain length unknown, 50% chlorinated) was tested for acute inhalation toxicity in rats at a vapour concentration of 48.17 g/m3 for 1 h. No deaths were reported and only slight nose and eye irritation were seen. Recovery occurred "soon" after exposure and remained normal throughout the [unspecified] observation period. The 1 h acute inhalation LC50 for Cereclor 50 HS is greater than 48.17 g/m3 (48.17 mg/L) and this test material would not be classified as acutely toxic by the inhalation route under EU CLP or DSD regulations.

In view of the similarities in structure and physiochemical properties [between SCCPs and MCCPs], together with the low acute oral toxicities of MCCPs, it can be predicted that MCCPs would also be of low acute toxicity by the inhalation route of exposure.