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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
An old study whic pre-dates GLP but method follows the principles of OECD 414

Data source

Reference
Reference Type:
publication
Title:
TERATOLOGY STUDIES OF A MIXTURE OF TALLOW ALKYL ETHOXYLATE AND LINEAR ALKYLBENZENE SULFONATE IN RATS AND RABBITS
Author:
GRANVILLE A. NOLEN, LLOYD W. KLUSMAN, LARRY F. PATRICK and
ROBERT G. GEIL
Year:
1975
Bibliographic source:
Toxicology, 4 (1975) 231--243

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
GLP compliance:
no
Remarks:
Study pre-dates GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Specific details on test material used for the study:
A mixture of 55% tallow alkyl ethoxylate sulfate (TAE 3 S) and 45% of linear alkylbenzene sulfonate (LAS)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Details on test animals and environmental conditions:
The rats were contained individually in suspended, stainless steel wire cages, except during the mating and nursing phases. Ground Purina Chow and water were available ad libitum throughout the study. The room temperature was maintained at 23 _+ 1 ° and the relative humidity at 50 -+ 5%. Lighting was maintained on a 12-h light--dark cycle

Administration / exposure

Route of administration:
oral: feed
Details on exposure:
The TAE 3 S/LAS was mixed into the ground commercial feed at levels of 0.1, 0.5 or 1.0% and fed to two generations of male and female rats continuously or only to females during each period of organogenesis (days 6--15) of pregnancy. A control group was fed commercial feed with no additive.
Details on mating procedure:
After becoming sexually mature, five rats of each sex per group were sacrificed for histology during each generation. The remaining animals were mated on a one-to-one basis three successive times during each generation. Pregnancies were confirmed and timed by the vaginal smear method and the day of finding sperm was designated day "0" of pregnancy. The first two pregnancies (F 1 a,1 b.2 a an a 2 b ) in each generation were allowed to proceed to natural births, while the third pregnancies in each generation (F1¢ and F2c ) were used for teratology.
Duration of test:
Days 6-15 of gestation
Doses / concentrationsopen allclose all
Dose / conc.:
80 mg/kg bw/day
Dose / conc.:
400 mg/kg bw/day
Dose / conc.:
800 mg/kg bw/day
No. of animals per sex per dose:
25/sex/dose

Results and discussion

Results: maternal animals

General toxicity (maternal animals)

Clinical signs:
not specified
Mortality:
mortality observed, non-treatment-related
Description (incidence):
6r ats in total died, 3 were in the control group and 3 in treated groups. heir deaths were due to disease and were not considered to be treatment related.
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Description (incidence and severity):
No significant differences were seen in the haematology values nor in the organ/body weight ratios.
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Other effects:
not specified
Details on results:
No significant differences in haematology values nor in the body/organ weight ratios.

Maternal developmental toxicity

Number of abortions:
no effects observed
Pre- and post-implantation loss:
no effects observed
Total litter losses by resorption:
no effects observed
Early or late resorptions:
not specified
Dead fetuses:
no effects observed
Changes in pregnancy duration:
not specified
Changes in number of pregnant:
not specified
Other effects:
not specified

Effect levels (maternal animals)

Key result
Dose descriptor:
NOAEL
Effect level:
800 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
other: No effects seen. NOAEL is highest tested dose

Results (fetuses)

Fetal body weight changes:
not specified
Reduction in number of live offspring:
no effects observed
Changes in sex ratio:
no effects observed
Changes in litter size and weights:
no effects observed
Changes in postnatal survival:
not specified
External malformations:
no effects observed
Skeletal malformations:
no effects observed
Visceral malformations:
no effects observed

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
800 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No effects seen. NOAEL is highest tested dose

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The test material did not show any developmental effects after rats were administered doses of hte test material through the organogenesis period. there were no significant differences in the number of resorptions at 13 days of gestation, thus no early embryotoxicity. In addition, there were no differences in the number of corpora lutea or total implantations in either generation. There were no significant foetal mortalities,a s indicated by the low number of dead foetuses and resorption sites in dams sacrificed at day 21 of pregnancy. Most of the soft tissue abnormalities seen in the rat foetuses were minor ones, more properly called variations rather than true defects such as hydrnephrosis, ectopic testes and folded retina, although two rats were seen with umbical hernia in the first generation. Similarly, the skeletal defects were minor in nature, including variations in the number of sternbrae, supernumeracy ribs and incomplete ossification
Executive summary:

The test material did not show any developmental effects after rats were administered doses of hte test material through the organogenesis period.  there were no significant differences in the number of resorptions at 13 days of gestation, thus no early embryotoxicity.  In addition, there were no differences in the number of corpora lutea or total implantations in either generation.  There were no significant foetal mortalities,a s indicated by the low number of dead foetuses and resorption sites in dams sacrificed at day 21 of pregnancy.  Most of the soft tissue abnormalities seen in the rat foetuses were minor ones, more properly called variations rather than true defects such as hydrnephrosis, ectopic testes and folded retina, although two rats were seen with umbical hernia in the first generation.  Similarly, the skeletal defects were minor in nature, including variations in the number of sternbrae, supernumeracy ribs and incomplete ossification