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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
developmental toxicity
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Rats were treated daily orally by gavage with the test item in water from day 6 to day 15 p.c.. The fetuses were delivered by cesarian section on the 20th day of gestation.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Naphthalenesulfonic acids, branched and linear Bu derivs., sodium salts
EC Number:
293-346-9
EC Name:
Naphthalenesulfonic acids, branched and linear Bu derivs., sodium salts
Cas Number:
91078-64-7
Molecular formula:
Not applicable (UVCB substance)
IUPAC Name:
Reaction products of naphtalene, butanol, sulfonated and neautralized by caustic soda
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Wistar

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Duration of treatment / exposure:
from day 6 to day 15 p.c.
Frequency of treatment:
daily
No. of animals per sex per dose:
27 female rats

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
10 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
body weight and weight gain
food consumption and compound intake

Results (fetuses)

Details on embryotoxic / teratogenic effects:
The following parameters of maternal toxicity were impaired:
 
the body weight gain in the 60 and 360 mg/kg group dams and the feed intake in the 360 mg/kg group (60 mg/kg marginally) were reduced during the treatment period. Decreased water consumption and reduced faeces excretion were observed in some dams of the 360 mg/kg group.
 
The following parameters on intrauterine development were affected:
 
In the 360 mg/kg group increased numbers of placentas with necrotic border and slightly reduced placental weights were observed. In the 360 mg/kg group increased numbers of fetuses with skeletal variations and retardations were observed. St the dosed of 360 mg/kg b.w. increased incidences of vertebral and multiple malformations that may occur spontaneously were evident, while the overall incidence of malformations was comparable between control and 360 mg/kg group. A treatment related effect for this slightly different distribution cannot be excluded.
 
However, primary developmental toxicity was not evident, since all embryotoxic findings observed at the dose of 360 mg/kg appeared in a maternally toxic dose range.

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
60 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
not specified
Basis for effect level:
skeletal malformations
other: increased numbers of placentas with necrotic border and slightly reduced placental weights.
Remarks on result:
other: Primary developmental toxicity was not evident, since all embryotoxic findings observed at the dose of 360 mg/kg appeared in a maternally toxic dose range.

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
NOAEL maternal toxicity: 10 mg/kg bw
NOAEL developmental toxicity: 60 mg/kg bw
Executive summary:

The developmental toxicity potential of the substance to rats was evaluated. Wistar rats were exposed to the substance, via the oral route, daily from day 6 to day 15 p.c. The following parameters of maternal toxicity were impaired:

the body weight gain in the 60 and 360 mg/kg group dams and the feed intake in the 360 mg/kg group (60 mg/kg marginally) were reduced during the treatment period. Decreased water consumption and reduced faeces excretion were observed in some dams of the 360 mg/kg group.  

The following parameters on intrauterine development were affected:

In the 360 mg/kg group increased numbers of placentas with necrotic border and slightly reduced placental weights were observed. In the 360 mg/kg group increased numbers of fetuses with skeletal variations and retardations were observed. St the dosed of 360 mg/kg b.w. increased incidences of vertebral and multiple malformations that may occur spontaneously were evident, while the overall incidence of malformations was comparable between control and 360 mg/kg group. A treatment related effect for this slightly different distribution cannot be excluded.

However, primary developmental toxicity was not evident, since all embryotoxic findings observed at the dose of 360 mg/kg appeared in a maternally toxic dose range.

NOAEL maternal toxicity: 10 mg/kg bw day

NOAEL developmental toxicity: 60 mg/kg bw day