Reaction products of hexane-1,6-diol with 2-(chloromethyl)oxirane (1:2)

Acute Toxicity: dermal

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

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-({[6-({1-chloro-3-[(oxiran-2-yl)methoxy]propan-2-yl}oxy)hexyl]oxy}methyl)oxirane; 2-[({6-[(oxiran-2-yl)methoxy]hexyl}oxy)methyl]oxirane; 3-chloro-2-({6-[(oxiran-2-yl)methoxy]hexyl}oxy)propan-1-ol; 6-[(oxiran-2-yl)methoxy]hexan-1-ol

EC Number:

618-939-5

Cas Number:

933999-84-9

Molecular formula:

C6H14O2 + C3H5ClO

IUPAC Name:

2-({[6-({1-chloro-3-[(oxiran-2-yl)methoxy]propan-2-yl}oxy)hexyl]oxy}methyl)oxirane; 2-[({6-[(oxiran-2-yl)methoxy]hexyl}oxy)methyl]oxirane; 3-chloro-2-({6-[(oxiran-2-yl)methoxy]hexyl}oxy)propan-1-ol; 6-[(oxiran-2-yl)methoxy]hexan-1-ol

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 or test system 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:

other: No signs of systemic toxicity or skin irritation were noted 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.