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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No OECD Guideline and GLP defined, acceptable restrictions (incomplete documentation).
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report date:
1971

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
other: single application (exposure time 3 or 5h), observation time: 7 d. Rats were exposed to a stream of vapour-saturated air. The vapour-air mixture was generated by passing 200 L/h of dried air at room temperature through 5 cm of the test substance contained in a gas-washing bottle.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzylamine
EC Number:
202-854-1
EC Name:
Benzylamine
Cas Number:
100-46-9
Molecular formula:
C7H9N
IUPAC Name:
1-phenylmethanamine
Test material form:
other: liquid
Details on test material:
- Name of test material: Benzylamin

Test animals

Species:
rat
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: mean 209.9 g (male); mean 172.9 g (male)

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Analytical verification of test atmosphere concentrations:
no
Concentrations:
0.4 mg/L (exposure time: 5 h); 0.65 mg/L (exposure time: 3 h)
No. of animals per sex per dose:
3m/3 f (exposure time: 5 h)
6m/6f (exposure time: 3 h)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 0.4 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
5 h
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 0.65 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
3 h
Mortality:
Male:
0/6 (exposure time: 3 h)           
1/3 (exposure time: 5 h)

Female:
0/6 (exposure time: 3 h)           
0/3 (exposure time: 5 h)
Clinical signs:
other: Severe Irritation of the mucous membrane, dyspnea (exposure time: 3 and 5 h).
Body weight:
No impairment of bodyweight development (exposure time: 3 and 5 h).
Gross pathology:
Exposure time: 5 h
1 male died: heart: blunted, both heart ventricles poorly contracted, filled with blood; liver: congestion.
All other animals without gross pathology findings.

Exposure time: 3 h
All animals without gross pathology findings.

Any other information on results incl. tables

At BASF’s Department of Toxicology, acute toxicity testing was performed according to published methods, which were adapted and standardized for the specific needs of the company, well before Test Guidelines for these methods were established by the OECD beginning 1982. These methods were comparable to the Union Carbide (now a DOW company) range finding toxicity data which have been published in the early toxicological literature (1944-1949). The results of these studies were reported until the early 1980s in summary reports called „Ergebnis der gewerbetoxikologischen Vorprüfung“ or „Toxikologische Grundprüfung“, which do not present details of the methods used, but focus on a summary presentation of the results.

Applicant's summary and conclusion