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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 December 12, 1989 to February 14, 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD 401 guideline study, but not in compliance with GLP.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
68425-47-8
Cas Number:
68425-47-8
IUPAC Name:
68425-47-8
Constituent 2
Reference substance name:
Amides, soya, N,N-bis(hydroxyethyl)
EC Number:
270-355-6
EC Name:
Amides, soya, N,N-bis(hydroxyethyl)
IUPAC Name:
270-355-6
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Marlamid DF 1818
- Physical state: liquid
- Lot/batch No.: 13

Test animals

Species:
rat
Strain:
other: Bor:WISW (SPF Cpb)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: F. Winkelmann, 4799 Borchen, Germany
- Weight at study initiation: 249 g
- Fasting period before study: > 16 h
- Housing: Groups of up to five by sex in solid-floor polypropylene cages
- Diet: R10 Alleindiät for rats, Ssniff Spezialfutter GmbH, 4770 Soest, ad libitum
- Water: Drinking water, ad libitum
- Acclimation period: 5-8 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 60 +/- 5%
- Air changes (per h): 15
- Photoperiod (h dark/h light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 3.09 cm3/kg
Doses:
3,000 mg/kg
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 d
- Frequency of clinical observation: Continuously up to 6 h post-treatment and subsequently once daily for 14 d
- Frequency of weighing: Pre-treatment , then on Days 1, 7 and 14
- Necropsy of survivors performed: Yes
- Examinations performed: Clinical signs, body weight and gross pathological examination

Results and discussion

Preliminary study:
No deaths or clinical signs of toxicity were observed
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 000 mg/kg bw
Mortality:
No mortality
Clinical signs:
other: All animals were in resting position 30 minutes after dosing. Three had slightly rough fur. Thirty minutes later, no symptoms were seen anymore.
Gross pathology:
Six animals showed local thickenings of the mucous membrane of the forestomach; in three of these animals, the mucous membrane of the stomach was slightly reddened.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the study conditions, the LD50 of the test susbtance in rat was found to be > 3,000 mg/kg bw. Hence, it does not warrant a classification according to EU CLP.
Executive summary:

A study was performed to assess the acute oral toxicity of amides, C16-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl) in Bor:WISW rat according to OECD Guideline 401.

A group of 20 fasted animals (10 males and 10 females) was administered a single oral dose of undiluted test substance at 3,000 mg/kg bw. The animals were observed for 14 d and were then sacrificed and subjected to gross pathological examination.

There were no mortalities. Transient signs of toxicity were observed 30 minutes after dosing, but no longer after that time point. Upon necropsy, thickening of the mucous membrane of the forestomach and slight reddening of the mucous membrane of the stomach was seen in some animals.

Under the study conditions, the LD50 of the test susbtance in rat was found to be > 3,000 mg/kg bw. Hence, it does not warrant a classification according to EU CLP.