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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998-09-08 to 1998-09-29
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline conform study report, GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Remarks:
Statement
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
N-acetylhexanelactam
EC Number:
217-565-6
EC Name:
N-acetylhexanelactam
Cas Number:
1888-91-1
Molecular formula:
C8H13NO2
IUPAC Name:
1-acetylazepan-2-one
Constituent 2
Reference substance name:
1888-91-0
IUPAC Name:
1888-91-0
Test material form:
other: liquid, clear yellowish
Details on test material:
- Name of test material: Acetylcaprolactam
- Physical state: liquid
- Analytical purity: 100%
- Lot/batch No.: Op.2
- Expiration date of the lot/batch: December 1999
- Stability under test conditions: guaranteed for 4 hours
- Storage condition of test material: darkness at room temperature in fume cupboard

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Doses:
1600, 2000 and 2500 mg/kg bw
No. of animals per sex per dose:
at 1600 mg/kg bw: 5 males/ 5 females
at 2000 mg/kg bw: 5 females
at 2500 mg/kg bw: 5 females
Control animals:
no
Statistics:
The LD50 and the equation of the probitline were established in female animals on the basis of the letahity rates by probit analysis.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
1 836 mg/kg bw
Based on:
test mat.
Mortality:
Under the conditions described the following lethality rates were observed:
males:
1600 mg/kg bw: absolute 0/5 males; relative: 0%
females:
1600 mg/kg bw: absolute 2/5 females; relative: 40%
2000 mg/kg bw: absolute 2/5 females; relative: 40%
2500 mg/kg bw: absolute 5/5 females; relative: 100%
Clinical signs:
other: Clinical sighn observed were: hypoactivity, stupor, sunken flanks, bristled coat, stilted gait, uncoordinated gait, ataxia, irregular respiration, narrowed palpebral fissures, prone position, absent paw reflex to pinching, absent righting reflex and narco
Gross pathology:
Macroscopic findings of animals found dead
Liver: light discoloration;
Stomach: detachment of the mucous membrane
Small intestine: diffuse reddening
Lung: discoloured red.
Animals sacrified at the scheduled end of observation period showed no macroscopically visible changes.

Any other information on results incl. tables

Under the conditions described the following lethality rates were observed:

males:

1600 mg/kg bw: absolute  0/5 males; relative: 0%

females:

1600 mg/kg bw: absolute  2/5 females; relative: 40%

2000 mg/kg bw: absolute  2/5 females; relative: 40%

2500 mg/kg bw: absolute  5/5 females; relative: 100%

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) in female Sprague Dawley rats was found to be 1836 mg/kg bw.
Executive summary:

In an OECD 401 study the acute oral median lethal dose (LD50) of the test substance to the Sprague Dawley strain rat was found to be 1836 mg/kg bw. Doses of 1600, 2000 or 2500 mg/kg bw in sesame oil were applied once to the rats by gavage. Whereas 1600 mg/kg bw was applied to 5 male and 5 female rats, the remaining two doses were applied to 5 female rats each. Mortality occured in 5/5 female rats at 2500 mg/kg bw, in 2/5 females at 2000 mg/kg bw and in 2/5 females at 1600 mg/kg bw. No death occurred in male rats at 1600 mg/kg bw.