Reaction product of "Fatty acids, C16-18 (even numbered) and C18-unsaturated" and "reaction mass of 1,3-alkanediol, 2-(hydroxymethyl)-2-[(methoxymethoxy)methyl]- and 1,3-heteromonocycle-5,5-dimethanol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 17-31, 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study has been performed according to OECD guidelines and according to GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Temporary deviations from the minimum level of relative humidity occurred. Evaluation: Laboratory historical data do not indicate an effect of the deviations.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

yes

Remarks:

Temporary deviations from the minimum level of relative humidity occurred. Evaluation: Laboratory historical data do not indicate an effect of the deviations.

Principles of method if other than guideline:

United States Environmental Protection Agency (EPA). Health Effects Test Guidelines, OPPTS 870.1200, Acute Dermal Toxicity. Office of Prevention, Pesticides and Toxic Substances (7101), EPA 712-C-96-192, August 1998. Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000; including the most recent partial revisions.

GLP compliance:

yes

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

liquid

Details on test material:

- Name of test material: Reaction products of Fatty acids, C16-18 and C18-unsatd. and reaction mass of 1,3-alkanediol, 2-(hydroxymethyl)-2-[(methoxymethoxy)methyl]- and 1,3-heteromonocycle-5,5-dimethanol
- Physical state: Light brown liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: The test substance was dosed undiluted as delivered by the sponsor.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

Signs of toxicity related to dose levels:
Piloerection or chromodacryorrhoea (snout) were noted in the majority of animals. The animals had recovered from the
symptoms between Days 2 and 3.

Body weight:

The changes noted in body weight gain in males and females were within the range expected for rats used in this type of
study and were therefore considered not indicative of toxicity.

Gross pathology:

Effects on organs:
No abnormalities were found at macroscopic post mortem examination of the animals.

Other findings:

Signs of toxicity (local):
Scales and/or maculate erythema were seen in the treated skin-area of three females during the observation period.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified.

Remarks:

According to Regulation (EC) 1272/2008

Conclusions:

The dermal LD50 value of Reaction products of Fatty acids, C16-18 and C18-unsatd. and reaction mass of 1,3-alkanediol, 2-(hydroxymethyl)-2-[(methoxymethoxy)methyl]- and 1,3-heteromonocycle-5,5-dimethanol in Wistar rats was established to exceed 2000 mg/kg body weight.