Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Study period:
29. Aug 1968 - 09. Sep 1968
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report Date:
1968

Materials and methods

Principles of method if other than guideline:
BASF test: The study was conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Butylal; Formaldehyddibutylacetal
- Physical state: liquid
- Analytical purity: 98-99 %

Test animals

Species:
rat
Strain:
other: US-rats
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 188 g (mean); female: 158 g (mean)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 30% aqueous emulsion in Traganth
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2, 20 and 30 %

Doses:
200, 1600, 3200, 6400 ml/kg bw (168, 1344, 2688, 5376 mg/kg bw; conversion into mg/kg is based on the density d= 0.84 g/cm3 according to GESTIS database)
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 376 mg/kg bw
Remarks on result:
other: mg/kg bw; conversion into mg/kg is based on the density d= 0.84 g/cm3 according to GESTIS database
Mortality:
5376 mg/kg bw: one male died within 24 h.
Clinical signs:
5376 mg/kg bw:
5 min after application irregular respiration, masticatory movement, watery mouth discharge, high stepping gait, piloerection.
24 h post application irregular respiration, latero-abdominal position and apathy were observed.

2688 mg/kg bw: on the day of application same symptoms as higher dose group and 24 h post application irregular respiration were noted.

168 and 1344 mg/kg bw: intermittent respiration, squatting posture, masticatory movements.


Body weight:
no data
Gross pathology:
Died animals:
1x increased nose secretion;
Lung: distended and blood filled;
Intragastric tract: atony with aqueous-mucous content;
Bladder: dilatation

Sacrificed animals:
5x bronchitis and bronchiectasis; 2x bronchial pneumonia; 4x intravesicular clot and moderate dilatation of the bladder.

Any other information on results incl. tables

Mortality:

Dose (mg/kg bw) Gender 1 h 24 h  48 h  7 days          
5376 male 0/10 1/10 1/10 1/10          
5376 female 0/10 0/10 0/10 0/10          
2608 male 0/10 0/10 0/10 0/10          
2608 female 0/10 0/10 0/10 0/10          
1344 male 0/10 0/10 0/10 0/10          
1344 female 0/10 0/10 0/10 0/10          
168 male 0/10 0/10 0/10 0/10          
168 female 0/10 0/10 0/10 0/10          

The test substance caused signs of slight systemic toxicity after a single ingestion but mortality only in high doses.

Applicant's summary and conclusion