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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
From 10/08/1995 to 24/08/1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented GLP study performed according to OECD Guideline 401.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
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): CI-46C
- Substance type: Amber liquid
- Physical state: Liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Buckshire Corp., Perkasie, PA 18944 (U.S.D.A. License # 23-BL)
- Age at study initiation:
- Weight at study initiation: The weight variation did not exceed +/- 20% of the mean weight for each sex.
- Fasting period before study: One group of ten (5 male & 5 female) albino rats was deprived of food but not water overnight prior to dosing.
- Housing: Stainless steel elevated wire mesh flooring, 5 rats/cage by sex.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: The rats were acclimated to the laboratory for at least 5 days prior to the initiation of the study.
- The females used in the study were nulliparous and non-pregnant.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.1 °C - 23.3°C
- Humidity (%): 66-73%
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The volume of liquid administered did not exceed 2 mL/100 g body weight.
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual weights were recorded on the day of dosing, weekly thereafter, and prior to necropsy. Changes in weight were calculated and reported.
- Necropsy of survivors performed: yes The animals were euthanized with carbon dioxide at the conclusion of the observation period. Gross necropsies were performed on all animals which die during the 14-day observation period, as well as those surviving the 14-day observation period.
- Other examinations performed: Animals were observed frequently on the day of dosing. A careful clinical examination was performed at least once each day (7 days/week). On weekdays, a second observation of mortality/moribundity was performed.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All animals survived during the 14 day observation period after administration of 2000 mg/kg of the substance
Clinical signs:
other: Males: Immediate - All animals appeared to be normal 2 hours - All animals appeared to be normal 4 hours - All animals appeared to be normal Days 1 - 10: All animals appeared to be normal Days 11 - 14: 1/5 animals exhibited audible breathing and 4/5 anim
Gross pathology:
Males:
No gross abnormalities were observed in any of the five animals necropsied at the conclusion of the 14-day observation period.

Females:
No gross abnormalities were observed in any of the five animals necropsied at the conclusion of the 14-day observation period.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance, when administered as supplied to 5 male and 5 female albino rats, appears to have an acute oral LD50 greater than 2000 mg/kg.