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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
three-generation reproductive toxicity
Remarks:
based on test type (migrated information)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented peer-reviewed publication.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1971

Materials and methods

Principles of method if other than guideline:
Na-LAS (chain length distribution C10-14) was fed for 84 days to 4 groups of weanling rats (3 dose levels, plus control), each dose consisting of 50 animals each of both sexes (PO-generation). When the P0 generation was 107-112 days old, 20 females from each dose group were mated with 20 males from the same group and maintained together for 17 days. The first litters of each generation (Fla- and F2a-generation) were sacrificed at 21 days of age. Ten days after the final litter was sacrificed, all females were remated with different males from the same group to obtain the F1b generation. From the Flb-generation, 20 males and females of each group were selected at weaning to continue their respective diets and to be used for further reproduction studies. Reproduction studies on the F1b and F2b generations were started when the rats were 80 to 85 days old, and were continued until the F3b generation was weaned.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Reference substance name:
Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts
EC Number:
270-115-0
EC Name:
Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts
Cas Number:
68411-30-3
Molecular formula:
C16-19 H25-31 Na O3 S
IUPAC Name:
sodium 4-undecylbenzenesulfonate
Details on test material:
- Name of test material (as cited in study report): Sodium salt LAS (C10-14)
- Activity: 98.1% on an anhydrous basis (41.9% active)
- Impurities (identity and concentrations): unreacted alkylbenzene and Na2SO4

Test animals

Species:
rat
Strain:
other: Charles River
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Vehicle:
not specified
Details on mating procedure:
premating exposure period 84 days
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
2 years ( 3 generations)
Frequency of treatment:
continuous in feed
Doses / concentrations
Remarks:
Doses / Concentrations:
0.02, 0.1, 0.5% (14, 70, 350 mg/kg bw d)
Basis:
actual ingested
No. of animals per sex per dose:
50 males and 50 females per group.
Control animals:
yes, concurrent no treatment

Examinations

Litter observations:
Deformities and number of pups, average body weights, feed consumption, feed efficiency.
Postmortem examinations (parental animals):
Necropsy, body weight, organ to body weight ratios, routine hematology and histology.
Postmortem examinations (offspring):
Necropsy, body weight, organ to body weight ratios, routine hematology and histology.

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
no effects observed
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Histopathological findings: non-neoplastic:
not specified
Other effects:
not specified

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)

No mortality or clinical signs were observed in parental animals. Body weight gains and organ to body weight ratios were normal. Gross examination revealed no abnormalities attributable to the test substance. General reproduction including fertility, gestation, parturition, neonatal viability, lactation, and post-weaning growth were normal for all test groups and did not vary from controls.

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
350 mg/kg bw/day
Sex:
male/female
Basis for effect level:
other: 0.5%

Results: F1 generation

General toxicity (F1)

Clinical signs:
not specified
Mortality / viability:
no mortality observed
Body weight and weight changes:
not specified
Sexual maturation:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
no effects observed
Histopathological findings:
no effects observed

Details on results (F1)

Rats sacrificed at weaning were normal with respect to growth, organ to body weight ratios, gross pathology, and histology, and did not vary from controls. There were a number of statistically significant hematologic values, though these differences were small and did not indicate a trend or pattern.

Effect levels (F1)

Dose descriptor:
NOAEL
Generation:
F1
Effect level:
350 mg/kg bw/day
Sex:
male/female
Basis for effect level:
other: 0.5%

Results: F2 generation

Effect levels (F2)

Dose descriptor:
NOAEL
Generation:
F2
Effect level:
350 mg/kg bw/day
Sex:
male/female
Basis for effect level:
other: 0.5%

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
No significant effects on reproduction were observed at the highest concentration tested.
Executive summary:

Na-LAS was fed for 84 days to 4 groups of weanling rats for two years (three generations). No significant effects were observed at the highest dose tested and the resulting NOAEL for the parental and both offspring generations was 350 mg/kg bw (0.5%)