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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Sufficiently well documented study similar to test guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
application twice within 2h; observation period 7d
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Montan wax
EC Number:
232-313-5
EC Name:
Montan wax
Cas Number:
8002-53-7
Molecular formula:
As montan wax is a UVCB, a molecular formular cannot be specified.
IUPAC Name:
Montan wax

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: VEB Versuchstierproduktion Schönwalde
- Weight at study initiation: female: 168 +/- 12g; male: 178 +/- 20g
- Fasting period before study: 16h
- Housing: 10 rate per cage
- Diet (e.g. ad libitum): R/3 VEB Versuchstierproduktion Schönwalde ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-2°C
- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: oil
Doses:
12000 mg/kg (6000 mg/kg applied within 2h)
No. of animals per sex per dose:
10
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
12 000 mg/kg bw
Based on:
test mat.
Mortality:
1 female rat died directly after application

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is practically non toxic within an LD50 > 12000 mg/kg bw.
Executive summary:

As only one out of 20 rats died while the other rats did not show any symptoms over the observation period of one week, the test substance is practically non toxic with an LD50 > 12000 mg/kg bw applied in two doses of 6000 mg/kg bw within two hours.