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

Endpoint summary

Description of key information

The acute oral study was performed according to OECD Guideline 423 and GLP principles and the acute dermal study was performed according to OECD Guideline 402 and GLP principles.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 02-21, 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.

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

Principles of method if other than guideline:

United States Environmental Protection Agency (EPA). Health Effects Test Guidelines, OPPTS 870.1100, Acute Oral Toxicity. Office of Prevention, Pesticides and Toxic Substances (7101), EPA 712-C-98-190, 2002. Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Vehicle:

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

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0

Clinical signs:

Signs of toxicity related to dose levels:
Hunched posture was noted in all animals on Day 1.

Body weight:

The body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.

Gross pathology:

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

Comments:
According to the OECD 423 test guideline, the LD50 cut-off
value was considered to exceed 5000 mg/kg body weight.

Interpretation of results:

other: Not classified.

Remarks:

According to Regulation (EC) 1272/2008.

Conclusions:

The oral 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.

Endpoint conclusion

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

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.

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.

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

Species:

rat

Strain:

Wistar

Sex:

male/female

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

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.

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.

Endpoint conclusion

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Oral:

In an acute oral toxicity study, according to OECD, EC, EPA and JMAFF test guidelines, female rats were exposed via gavage to 2000 mg/kg bw of Radia 7853. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice. No mortality occurred. Hunched posture was noted in all animals on Day 1 only. Bodyweight gain was considered normal and no abnormalities at macroscopic examination were found. Therefore, the oral LD50 of Radia 7853 in rats was establised to exceed 2000 mg/kg bw.

Dermal:

In an acute dermal study, performed according to OECD, EC, EPA and JMAFF test guidelines, rats were exposed by a single dermal application to 2000 mg/kg bw of Radia 7853 for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice. No mortality occurred. Piloerection or chromodacryorrhoea (snout) were noted in the majority of animals. The animals had recovered from the symptoms between Days 2 and 3. Scales and/or maculate erythema were seen in the treated skin-area of three females during the observation period. Bodyweight gain was considered normal and no abnormalities at macroscopic examination were found. Therefore, the dermal LD50 of Radia 7853 in rats was establised to exceed 2000 mg/kg bw.

Justification for classification or non-classification

Based on the available data, the substance does not have to be classified for acute toxicity according to the CLP Regulation (EC) No 1272/2008.