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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
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:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
In principle, the methods described in the OECD Guideline 401 were used. Young adult laboratory rats were purchased from breeder. Several groups of 5 rats per sex and dose were treated simultaneously by gavage with preparations of the test substance in suitable vehicle. The concentrations of these preparations were used to achieve comparable volumes per kg body weight. Group-wise documentation of clinical signs was performed over the 14 day study period.
GLP compliance:
no
Remarks:
; GLP was not compulsory at the time the study was conducted
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation:
mean body weight, males: 160 g in the 5000 mg/kg b.w. group
mean body weight, males: 140 g in the 2150 mg/kg b.w. group
mean body weight, females: 150 g in the 5000 mg/kg b.w. group
mean body weight, females: 160 g in the 2150 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:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50 % and 21.5 % for the 5000 and 2150 mg/kg b.w. dose level, respectively
- Amount of vehicle (if gavage): 10 ml/kg b.w.
Doses:
2150, 5000 mg/kg b.w.
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 were observed and examined for clinical signs of toxicity during the first hour following application, after 4 and 5 hours and further on day 1, 2, 3, 6, 8, 9, 10 and 13 after dosing.
Mean body weights were determined for the following intervals of time: 2-4, 6-7 and 9-13 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:
> 5 000 mg/kg bw
Remarks on result:
other: One female in the 5000 mg/kg bw dose group died during the observation period, at day 7 after application
Mortality:
All males survived. One female in the 5000 mg/kg bw dose group died during the observation period, at day 7 after application.
Clinical signs:
No signs of toxicity were reported for the low dose group. For the high-dose group dyspnea (2 cases), aggressiveness (1 case), spastic walk (1 case) and bad general condition (1 case) were reported only at day 3 after application.
Body weight:
For details, see table 1 below.
Gross pathology:
Necropsy of the female rat that died at day 5:
Acute congestion of the heart and dilatation of the atrium, substance-coloured content in gastrointestinal tract.

Necropsy of the survivors which were sacrificed after the end of the observation period of 14 days:
Findings were observed in the stomach and included thickening and plication of forestomach as well as its agglutination with liver, peritoneum, and spleen.

Any other information on results incl. tables

Table 1: Mean body weight of rats after oral application of Hexandiolacrylate, technical grade

 

    Males

    Females

 Dose level [mg/kg bw]

 5000

 2150

 5000

 2150

 Day 2-4

 170

171 

146 

182 

 Day 6-7

 196

200 

169 

193 

 Day 9-13

 239

212 

192 

193 

Applicant's summary and conclusion