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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: other routes

Currently viewing:

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
BASF-Test:
Young adult laboratory mice were purchased from breeder. Several groups of 5 mice per sex and dose were treated simultaneously with preparations of the test substance in suitable vehicle. The substance was injected into the peritoneal cavity. The concentrations of the preparations were used to achieve comparable volumes per kg body weight. Group-wise documentation of clinical signs was performed over the study period of 14 days.
GLP compliance:
no
Remarks:
; GLP was not compulsory at the time the study was conducted
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexamethylene diacrylate
EC Number:
235-921-9
EC Name:
Hexamethylene diacrylate
Cas Number:
13048-33-4
Molecular formula:
C12H18O4
IUPAC Name:
hexane-1,6-diyl bisacrylate
Details on test material:
- Name of test material (as cited in study report): 1,6-Hexanedioldiacrylate
- Physical state: liquid
- Analytical purity: > 90 % (techn.)

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation:
mean body weight, males: 24 g in the 700 mg/kg b.w. group
mean body weight, males: 24 g in the 200 mg/kg b.w. group
mean body weight, females: 24 g in the 700 mg/kg b.w. group
mean body weight, females: 24 g in the 200 mg/kg b.w. group
- Fasting period before study: 15-20 hours
- Diet: Herilan MRH-Haltung; H. Eggersmann KG, ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
CMC (carboxymethyl cellulose)
Details on exposure:
DOSAGE PREPARATION:
- Stock solutions prepared:
2 % for the 200 mg/kg bw dose group,
7% for the 700 mg/kg bw dose group,
- Dose volume applied:
10 ml/kg bw of the 2% stock solution for the 200 mg/kg bw dose group,
10 ml/kg bw of the 7% stock solution for the 700 mg/kg bw dose group.

Doses:
200 mg/kg bw, 700 mg/kg bw
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Details on study design:
Duration of observation period following administration:
14 days
- Frequency of observations and weighing:
Animals of the 700 mg/kg bw dose group were observed and examined for clinical signs of toxicity during the first hour following application, after 2, 4 and 5 hours and further on day 1, 4, 5, 6, 7, 8, 11 and 13 after dosing.
Animals of the 200 mg/kg bw dose group were observed and examined for clinical signs of toxicity during the first hour following application, after 2, 4 and 5 hours and further on day 3, 4, 5, 6, 7, 10, 11 and 13 after dosing.
Mean body weights were determined for the following intervals of time: 2-4, 7 and 13 days of the study.
- Necropsy of survivors performed: yes
Deceased animals and those sacrificed at the end of the observation period were necropsied.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 700 mg/kg bw
Mortality:
No mortalities in the 200 mg/kg bw dose group. 6/10 mortalities (one male at day 4, two males at day 6 after application, one female each at day 5, 6 and 7 after application) in the 700 mg/kg bw dose group.
Clinical signs:
in the 700 mg/kg bw dose group:
Dyspnea, apathy, spastic walk, stretching, unkempt fur, exsiccosis and bad general condition were observed following application lasted until day 5 of observation.


in the 200 mg/kg bw dose group:
Dyspnea, apathy, spastic walk, unkempt fur and bad general condition were observed during the first 5 hours after application. No more symptoms were seen for the remaining period of observation.
Body weight:
For details, see table 1 below.
Gross pathology:
At both dose levels, intraabdominal substance deposition or agglutination was observed.
No further findings were documented.

Any other information on results incl. tables

Table 1: Mean body weight of mice after intraperitoneal application of Hexandiolacrylate, technical grade

 

    Males

    Females

 Dose level [mg/kg bw]

 700

 200

 700

 200

 Day 2-4

 22.5

28.2

22.2

24.2

 Day 7

27.0

30.0

25.0

25.6

 Day 13

 30.0

30.2

29.0

27.4

Applicant's summary and conclusion