Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

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

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
sprague-Dawley rats were obtained from Bantin & Kingman Ltd, Hull UK and were approximately ten to fourteen weeks of age. The males weighted 216 - 244 gm and the females weighted 211 - 232 gm upon arrival. The animals were grouped housed, 5 per polypropylene cage. Mains drinking water and feed (Rat and Mouse Expanded Diet No. 1, Special Diet Services Ltd, Essex, UK) were provided ad libitum. The animal room was maintained at 21 - 23 degrees with 54 - 67% relative humidity and a light/dark cycle of 12 hr. The rate of air exchange was approximately 15 per hour.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
To an approximate 5 cm x 4 cm area on the back and flank of each animal the appropriate volume of neat test substance based upon specific gravity and animal body weight as applied using a graduated syringe. A piece of aluminium foil measuring approximately 7 cm x 4 cm was placed over the treated site. The site was occluded with a piece of self-adhesive bandage (HYPERTIE). The treated occluded area was secured BLENDERN wrap.
Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Animals were dermally exposed with occlusion to 1,6-Hexanediol Diglycidylether (HDDGE) for approximately 24 hr. Following the treatment period, the wrapping and dressing were removed and the treated area cleaned. The animals were observed for clinical signs and mortality 1 and 4 hr aftering dosing and at least once daily thereafter for 14 days. Body weights were taken the day of treatment (study day 0) and at study days 7 and 14. All animals were subjected to a gross necrospy and macroscopic examination.
Statistics:
No data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: NOEL
Effect level:
2 000 mg/kg bw
Mortality:
No mortalities.
Clinical signs:
No signs of systemic toxicity or skin irritation were noted during the study.
Body weight:
All animals showed expected bodyweight gain during the study.
Gross pathology:
No abnormalities were noted at necropsy of animals sacrificed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information via the dermal route of exposure. Criteria used for interpretation of results: expert judgment
Conclusions:
The no observed effect level (NOEL) of the test material, 1,6-Hexanediol Diglycidylether , in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg bodyweight. Therefore, Classification and Labeling for acute dermal exposure is not required.
Executive summary:

1,6-Hexanediol Diglycidylether (HDDGE) was evaluated for acute dermal toxicity potential to rats in an O.E.C.D. 402 Testing Guideline study conducted with GLP compliance. No mortalities were observed in the study. The no observed effect level (NOEL) of the test material, 1,6-Hexanediol Diglycidylether , in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg bodyweight. Therefore, Classification and Labeling for acute dermal exposure is not required.