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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented non-GLP study with some minor deviations: four instead of five animals per sex per dose are used. For half of the test animals, the skin is abraded before application of the test substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Four instead of five animals per sex per dose are used. At half of the test animals, the skin is abraded before application of the test substance.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Fatty acids, tall-oil, reaction products with formaldehyde and (Z)-N-9-octadecenyl-1,3-propanediamine
EC Number:
272-789-1
EC Name:
Fatty acids, tall-oil, reaction products with formaldehyde and (Z)-N-9-octadecenyl-1,3-propanediamine
Cas Number:
68911-83-1
Molecular formula:
C40H76N2O
IUPAC Name:
Fatty acids, tall-oil, reaction products with formaldehyde and (Z)-N-9-octadecenyl-1,3-propanediamine
Details on test material:
- Name of test material (as cited in study report): 46C

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: between 2.0 and 2.5 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
All animals had their backs clipped free of hair 24 hours prior to testing. One half of the animals had their backs abraded prior to dosing.
These treated areas were covered with large gauze patches and an impervious material was wrapped snugly around the trunk of each animal.

REMOVAL OF TEST SUBSTANCE
The dressings were removed after 24 hours and any excess material was removed and the appropriate amount remaining was noted.


Duration of exposure:
24 hours
Doses:
1000 mg/kg
2000 mg/kg
4000 mg/kg
8000 mg/kg
No. of animals per sex per dose:
4 albino rabbits
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All rabbits were weighed prior to application of the test substance
- Necropsy of survivors performed: yes (gross autopsies were performed on all animals which died during the 14 day observation period)

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 8 000 mg/kg bw
Based on:
test mat.
Mortality:
1000 mg/kg: no animals died
2000 mg/kg: no animals died
4000 mg/kg: 1 animal died at day 2
8000 mg/kg: 1 animal died at day 2 and 1 animal died at day 3
Clinical signs:
other: No details provided.
Gross pathology:
No details provided.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance as tested in rabbits has an acute dermal LD50 approximately 8000 mg/kg.