Reaction mass of 3,7-dimethyl-1-octyl acetate and citronellyl acetate

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

The Geraniol / Nerol (60/40% reaction mass also called Geraniol 60) is the key information for repeated dose toxicity, derived from its developmental toxicity (OECD TG 414), which showed the lowest NOAEL.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Reference

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: read across

Justification for type of information:

The information is based on read across from Geraniol / Nerol (60/40% reaction mass also called Geraniol 60) from a developmental toxicity study (OECD TG 414, because this study has the lowest NOAEL for repeated dose toxicity. The documentation is presented in the read across rationale presented in the Repeated dose toxicity Endpoint summary, the accompanying files are also attached there.

Reason / purpose for cross-reference:

read-across source

Remarks:

This study has the lower NOAEL

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Body weight and weight changes:

effects observed, treatment-related

Key result

Dose descriptor:

NOAEL

Effect level:

100 mg/kg bw/day (actual dose received)

Based on:

test mat.

Sex:

female

Basis for effect level:

body weight and weight gain

Key result

Critical effects observed:

yes

Lowest effective dose / conc.:

300 mg/kg bw/day (actual dose received)

System:

other: body weight decrease

Organ:

other: body weight decrease

Treatment related:

yes

Dose response relationship:

yes

Relevant for humans:

yes

Conclusions:

The repeated dose toxicity NOAEL for Citronellyl Acetate Multi used for risk assessment is derived from Geraniol / Nerol (60/40% reaction mass; Geraniol 60) which was tested in an OECD TG 414, where maternal body weight was decreased at 1000 and 300 mg/kg bw and a NOAEL of 100 mg/kg bw was derived. The body weight changes is a somewhat similar effect as was seen in the repeated dose toxicity study with Geranyl acetate and the study period of the 13 wk study is considered applicable.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: OECD TG 414

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of (2E)-3,7-dimethylocta-2,6-dien-1-ol and (2Z)-3,7-dimethylocta-2,6-dien-1-ol

EC Number:

906-125-5

Molecular formula:

Unspecified

IUPAC Name:

Reaction mass of (2E)-3,7-dimethylocta-2,6-dien-1-ol and (2Z)-3,7-dimethylocta-2,6-dien-1-ol

Details on test material:

liquid, colorless, clear

Test animals

Species:

rat

Sex:

female

Administration / exposure

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

100 mg/kg bw/day (actual dose received)

Doses / concentrations 2

Dose / conc.:

300 mg/kg bw/day (actual dose received)

Doses / concentrations 3

Dose / conc.:

1 000 mg/kg bw/day (actual dose received)

Results and discussion

Results of examinations

Body weight and weight changes:

effects observed, treatment-related

Description (incidence and severity):

The mean body weight gain of the mid and high dose rats was 13% and 14% lower than the control group.

Effect levels

Key result

Dose descriptor:

NOAEL

Effect level:

100 mg/kg bw/day (actual dose received)

Based on:

test mat.

Sex:

female

Basis for effect level:

body weight and weight gain

Remarks on result:

other: information from an OECD TG 414 study

Target system / organ toxicity

Key result

Critical effects observed:

yes

Lowest effective dose / conc.:

300 mg/kg bw/day (actual dose received)

System:

other: Body weight decrease

Organ:

other: body weight decrease

Treatment related:

yes

Dose response relationship:

yes

Relevant for humans:

yes

Applicant's summary and conclusion

Conclusions:

The NOAEL for repeated dose toxicity is 100 mg/kg bw in a developmental toxicity study according to OECD TG 414.

Executive summary:

For Geraniol 60 a prenatal developmental study was performed according to OECD TG 414 and in compliance with GLP criteria. In this study, doses were 100, 300 and 1000 mg/kg bw/day test item in corn oil.

The mean body weight gain of the mid and high dose rats was 13% and 14% lower than the control group. Based on these findings, the NOAEL for repeated dose toxicity in this study is 100 mg/kg bw.