Reaction products of 2,2-dimethylpropane-1,3-diol with 1-choloro-2,3-epoxypropane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

It is tested in a GLP laboratory.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

(24th February 1987)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

1

Reference substance name:

Reaction products of 2,2-dimethylpropane-1,3-diol with 1-chloro-2,3-epoxypropane

EC Number:

701-333-0

Molecular formula:

C11H20O4

IUPAC Name:

Reaction products of 2,2-dimethylpropane-1,3-diol with 1-chloro-2,3-epoxypropane

Details on test material:

It is a UVCB substance.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Species / Strain: Wistar rats (Crl:WI)
Source: Toxi-Coop Zrt. 1103 Budapest, Cserkesz u. 90.
Hygienic level: SPF at arrival and kept in a good conventional environment during the study
Number of animals:
(preliminary study) 2 female animals/dose
Number of animals:
(main study) 5 animals/dose
Age of animals: Young adult rats, females are nulliparous and non-pregnant
Sex: full test: 5 female animals/dose followed by 5 male animals/dose (at least one group), limit test: female and male animals
Planned body weight
range at starting: between 200 g and 300 g
Acclimatisation time: at least 5 days

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

not specified

Details on dermal exposure:

The back of animals was shaven (approximately 10 % area of the total body surface) 24 hours prior to the treatment. The test item was applied in a single 2000 mg/kg bw dose uniformly over the shaved skin and kept in contact throughout a 24- hour exposure period. Sterile gauze pads were placed on the skin of rats. These gauzes were kept in contact with the skin by a patch with adhesive hypoallergenic plaster. The entire trunk of the animal was wrapped with semi occlusive plastic wrap for 24 hours. At the end of the exposure period, residual test item was removed, using an appropriate vehicle at body temperature.

Duration of exposure:

A single administration was performed by dermal route and was followed by a 7-day observation period in preliminary study and 14-day observation period in main study.

Doses:

The test item was not expected to be lethal at 2000 mg/kg bw on the basis of the results obtained in the preliminary study (no deaths were observed in the preliminary study at 50, 200, 1000 and 2000 mg/kg bw dose levels). Thus, a limit test was performed.

No. of animals per sex per dose:

2000 mg/kg: 2 female animals, 1000 mg/kg: 2female animals, 200 mg/kg: 2female animals, 50 mg/kg: 2 female animals, 2000 mg/kgbw : 5 male and 5 female animals

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred after the 24-hour dermal exposure to Reaction products of 2,2-dimethylpropane-1,3-diol with 1-chloro-2,3-epoxypropane in male and female rats during the study.

Clinical signs:

other: No behavioural changes or signs of systemic toxicity were noted during the study. Dermal irritation symptom as erythema and other sign as wound and crusting were observed on the treatment site. Slight to well defined erythema (score 1, 2) appeared in thr

Gross pathology:

All animals survived until the scheduled necropsy on Day 15. Internal necropsy finding as hydronephrosis on the right side was observed in two male animals (No.: 6729, 6730). This alteration could not be related to the test item toxic effect, but was regarded an individual variation. Severe hydrometra was recorded in three females (No.: 6718, 6720, 6721). The hydrometra is a physiological finding and connected to the cycle of the animal. No pathological changes were found related to the effect of the test item during the macroscopic examination of animals.

Other findings:

No death occurred after a single 2000 mg/kg bw dermal dose of Reaction products of 2,2-dimethylpropane-1,3-diol with 1-chloro-2,3-epoxypropane. There were no systemic toxic clinical signs and any test item related effect found in body weights and body weight gains during the study. The dermal irritation symptoms observed could be connected with the test item effect. Autopsy revealed no treatment related pathological changes.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions applied, the acute dermal LD50 value of the test item Reaction products of 2,2-dimethylpropane-1,3-diol with 1-chloro-2,3-epoxypropane was estimated to be greater than 2000 mg/kg bw in male and female Crl:WI rats.

Executive summary:

It is not classified as acute toxicity dermal. No lethality was noted at single dermal dose of 2000 mg/kg bw