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Diss Factsheets

Toxicological information

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
toxicity to reproduction
Remarks:
other: 4 generation study
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1960-2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This is a summary of studies reviewed by the expert groups of the OECD High Production Volume (HPV) Chemicals Programme (SIDS Review Committee), JECFA and the U.S. Cosmetic Ingredient Review Expert Panel (CIR), which accepted the data as scientifically valid.. Documentation details may be missing as the studies were carried out some years ago and did not always fulfill present-day guidelines.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1960
Report date:
1960
Reference Type:
review article or handbook
Title:
Safety assessment of alkyl benzoates as used in cosmetics
Author:
Becker LC, Bergfeld WF, Belsito DV, et al.
Year:
2012
Bibliographic source:
Int. J. Toxicol. 31:342S-72S
Reference Type:
review article or handbook
Title:
SIDS Initial Assessment Report for the 13th SIAM: Benzoates
Author:
OECD HPV Programme
Year:
2001
Bibliographic source:
http://www.inchem.org/documents/sids/sids/BENZOATES.pdf
Report date:
2001

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: OECD guideline 416
GLP compliance:
not specified
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Benzoic acid
EC Number:
200-618-2
EC Name:
Benzoic acid
Cas Number:
65-85-0
IUPAC Name:
benzoic acid
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Details on exposure:
0.5 or 1 % in diet (approx. 375 or 750 mg/kg/day)
Analytical verification of doses or concentrations:
not specified
Doses / concentrations
Remarks:
Doses / Concentrations:
375 and 750 mg/kg/day
Basis:
nominal in diet
20 rats were fed contineuously with 375 or 750 mg/kg bw
No. of animals per sex per dose:
20 Rats per sex/ group
Control animals:
yes, plain diet

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
no effects observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Other effects:
no effects observed

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:
no effects observed
Reproductive function: sperm measures:
no effects observed
Reproductive performance:
no effects observed

Details on results (P0)

In all 4 generations, no effects on fertility (“Fortpflanzung”) and lactation (“Aufzugt der Jungen”) were found.

Effect levels (P0)

Key result
Dose descriptor:
NOAEL
Remarks:
750
Effect level:
>= 750 - <= 800 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
body weight and weight gain

Results: P1 (second parental generation)

Effect levels (P1)

Key result
Dose descriptor:
NOAEL
Effect level:
>= 750 - ca. 800 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
body weight and weight gain

Results: F1 generation

General toxicity (F1)

Clinical signs:
no effects observed
Mortality / viability:
no mortality observed
Body weight and weight changes:
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings:
no effects observed

Details on results (F1)

No effect was found in all 4 generations under this study.

Results: F2 generation

Effect levels (F2)

Key result
Dose descriptor:
NOAEL
Generation:
F2
Effect level:
>= 750 - 800 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
body weight and weight gain

Overall reproductive toxicity

open allclose all
Reproductive effects observed:
not specified
Key result
Reproductive effects observed:
no

Any other information on results incl. tables

In all 4 generations no influence on growth (weight, weight gain and food efficiency and organ weights was found. In all 4 generations no effects on fertility (Forzplanzung) and lactation (Aufzugtder Jungen) was found.In addition aso-called "Alters Paarung" after 48 weeks gave no influence on start of menopause.

Applicant's summary and conclusion

Conclusions:
Benzoic acid was administered in the diet to rats for 4 consecutive generations. In all 4 generations, no effects on fertility and lactation were found. The substance is not a reproductive toxicant. This study is informative for evaluation of the toxicity of members of the Alkyl Benzoates category, and is adequate for filling the data requirement for the registration of this substance. It is valid for hazard classification and risk assessment.