Registration Dossier

Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Remarks:
based on test type (migrated information)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The assessment is not possible to rate as it is based on published robust study summaries rather than the actual study reports. The authors consider the key study with CAS# 61789-01-3 Fatty acids, tall-oil, epoxidized, 2-ethylhexyl esters to be reliable without restriction.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2006
Report date:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Reference substance name:
Fatty acids, tall-oil, epoxidized, 2-ethylhexyl esters
EC Number:
263-024-2
EC Name:
Fatty acids, tall-oil, epoxidized, 2-ethylhexyl esters
Cas Number:
61789-01-3
IUPAC Name:
61789-01-3
Details on test material:
Fatty acids, tall-oil, epoxidized, 2-ethylhexylesters, 100% pure

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on exposure:
A standard dose volume of 2 mL/kg body weight with a daily adjustment to the actual body weight was used.
Duration of treatment / exposure:
Males: at least 28 days
Females: 14 days prior to pairing, throughout pregnancy until postnatal day 4
Frequency of treatment:
Daily
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 100, 300, 1000 mg/kg bw/day
Basis:
actual ingested
Control animals:
yes, concurrent vehicle

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female

Results: F1 generation

Details on results (F1)

No test article-related abnormal findings were noted for pups at first litter check or during the first four days post partum. Sex ratios at first litter check and on day 4 post partum were unaffected by treatment. Mean pup weights on day 0 and day 1 post partum were unaffected by treatment
with the test item. Mean pup weight development during the first 4 days post partum was unaffected by treatment with the test article. There were no test article-related macroscopic findings noted during necropsy of F1 pups.

Effect levels (F1)

Dose descriptor:
NOAEL
Generation:
F1
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
No studies were available for the registered substance. An OECD 422 study is available for the analagous substance, CAS # 61789-01-3 (ETP). No test article related adverse signs of toxicity were observed for this substance and the NOAEL was determined to be 1000 mg/kg bw/day.
Executive summary:

No studies were available for the registered substance. An OECD 422 study is available for the analagous substance, CAS # 61789-01-3 (ETP). No test article related adverse signs of toxicity were observed for this substance and the NOAEL was determined to be 1000 mg/kg bw/day. ETP was administered once daily orally (by gavage) to male rats for at least for 28 days and to female rats throughout the 14 day pre-pairing period, throughout pairing and gestation up to lactation day 4 according to OECD Guideline 422 (RCC, 2005b). The dose levels were 0 (vehicle control), 100, 300 and 1000 mg/kg bw/d. No test article-related mortalities or clinical signs were noted throughout the study. None of the parameters under investigation during the functional observational battery gave any indication of test item-related effects. Neither food consumption nor body weight development was affected by treatment with ETP at any dose level. The assessment of clinical chemistry and hematology parameters indicated no differences between animals treated with ETP and vehicle controls. During necropsy of parent animals no test article- related findings were noted. For males treated at 300 and 1000 mg/kg bw/d, mean absolute and relative liver weights were dose-dependently increased. For females treated at 1000 mg/kg bw/d, mean absolute and relative liver weights were increased. Histopathological findings included the following: Minimal hepatocellular hypertrophy in animals treated at 1000 mg/kg bw/d. This change was considered to represent an adaptive reaction most likely induced by an increased biotransformation of the test article. This was not considered an adverse effect. Increased incidence of minimal follicular cell hypertrophy in the thyroid of animals treated with 1000 mg/kg bw/d. The NOAEL for ETP in this reproduction screening study was considered to be 1000 mg/kg bw/d.