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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
As per IUCLID5 Sections 1.1 - 1.4.

Test animals

Species:
rat
Strain:
other: Tif: RAIF (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
The rats at 7to 8 weeks of age were supplied by CIBA-GEIGY Experimental Toxicology Sisseln. The animals were maintained in groups of five in Macrolon type 3 cages at 22 +/- 2 degrees C and a relative humidity of 45 - 65% with a 12 hr light/dark cycle. The animals were offered rat feed and water ad libitum.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5% CMC plus 0.1% Tween 80.
Details on oral exposure:
Animals fasted overnight were dosed by oral gavage by means of a stomach tube.
Doses:
1000, 2500, and 5000 mg/kg of body weight
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Animals were treated with a single dose of the test substance suspension by oral gavage. Mortality and clinical signs were monitored throught the entire study period of 14 days. Body weights were taken on study days 1, 7 and 14. All animals placed on study were submitted to necrospy with full macroscopic examination.
Statistics:
Logit model for LD50 estimation.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 010 mg/kg bw
95% CL:
2 214 - 4 913
Mortality:
Mortality was complete (10/10) at the high dose of 5000 mg/kg within 24 hr of dosing. One female animal was found dead in the 2500 mg/kg dose group at 24 hr post-dosing.
Clinical signs:
Yes
Body weight:
The body weight increase of surviving animals was generally normal.
Gross pathology:
No macroscopic pathology was observed.

Applicant's summary and conclusion

Interpretation of results:
relatively harmless
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The acute oral LD50 of 1,6-Hexanediol Diglycidylether (HDDGE) in rats of both sexes observed over a period of 14 days is 3010 (2214-4913) mg/kg of body weight.
Executive summary:

1,6-Hexanediol Diglycidylether (HDDGE) was evaluated for acute oral toxicity to rats in a manner similar to O.E.C.D. Testing Guideline 401. Complete mortality (10/10) was observed at the high dose level of 5000 mg/kg of body weight. The acute oral LD50 of 1,6-Hexanediol Diglycidylether (HDDGE) in rats of both sexes observed over a period of 14 days is 3010 (2214-4913) mg/kg of body weight suggesting that HDDGE is relatively non-toxic by the oral route od adminsitration.