Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03.08.1995 to 13.10.1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-chlorotetradecane
EC Number:
219-368-0
EC Name:
1-chlorotetradecane
Cas Number:
2425-54-9
Molecular formula:
C14H29Cl
IUPAC Name:
1-chlorotetradecane
Test material form:
liquid
Details on test material:
IUCLID Test substance: as prescribed by 1.1 - 1.4

Test animals

Species:
rat
Strain:
other: Hsd/Cpb: WU (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS:
- Strain: Rat / Hsd/Cpb: WU (SPF)
- Number and sex: 10 animals (5 males and 5 females)
- Breeder: Harlan Winkelmann
- Body weigth: 200 - 300 g

ENVIRONMENTAL CONDITIONS:
- Diet: a certified commercial diet (ssniff® R 10) ad libitum
- Water: tab water ad libitum
- Housing singly in MAKROLON cages (type III)
- Temperature: 22°C ± 3°C
- Rel. Humidity: 30% - 70%
- Light/dark period: 12/12h
- Acclimation operiod: at least 5 days

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 h
Doses:
2000 mg/kg, application volume 2.3 ml/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
The exposure of the test substance was 24 hours, dermal semiocclusive  application. After 24 hours the treated skin was cleaned with corn oil.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality. 
Clinical signs:
No systemic clinical symptoms were observed.
Body weight:
No changes in body weight gain were observed.
Gross pathology:
No macroscopic organ changes were observed.
Other findings:
Local effects: Up to 72 hours after application, slight to moderate edema  and erythema were observed. After 48 h desquamation and hardening of the skin was observed. The symptoms disappeared up to day 13 after treatment.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the described test conditions, mortality did not occur up to the highest dose tested of 2000 mg/kg/bw. Thus, the LD50 is above 2000 mg/kg/bw, and according to Regulation (EC) 1272/2008 the data are conclusive but not sufficient for classification.