Disodium oxybis[methylbenzenesulphonate]

Toxicity to reproduction: other studies

Administrative data

Endpoint:

toxicity to reproduction: other studies

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: In this guideline study according to OECD TG 407 and GLP reproductive organs of male and female rats were examined for adverse effects.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD TG 407

GLP compliance:

yes

Type of method:

in vivo

Test material

Test material information

Constituent 1

Reference substance name:

Disodium oxybis[methylbenzenesulphonate]

EC Number:

277-242-0

EC Name:

Disodium oxybis[methylbenzenesulphonate]

Cas Number:

73037-34-0

Molecular formula:

C14H12Na2O7S2

IUPAC Name:

disodium oxybis(methylbenzenesulfonate)

Test material form:

solid

Details on test material:

Active content reported: 90-95 %

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: males 153-173 g, females 133-151 g
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 55
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on exposure:

All animals were treated with the test item or vehicle for 7 days per week for a period of 28 days.
The test item formulation or vehicle was administered at a single dose to the animals by oral gavage.
For each animal the individual dosing volume was calculated on the basis of the body weight most recently measured.
The application volume for all groups was 5 ml/kg bw .

Analytical verification of doses or concentrations:

yes

Details on analytical verification of doses or concentrations:

Determination of the nominal concentration in dosing formulations including stability and and homogenicity.

Duration of treatment / exposure:

28 days

Frequency of treatment:

daily, 7 days per week

Duration of test:

28 days

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 100, 300, 1000 mg/kg bw/day
Basis:

No. of animals per sex per dose:

5

Control animals:

yes, concurrent vehicle

Details on study design:

The test item was administered 7 days per week in graduated doses to 3 groups of male and 3 groups of female rats.
Animals of an additional control group were handeled identically.
All animals were observed daily for clinical signs.
Body weight and food conclumption was measured twice weekly.
Determination of hematology values and clinical chemistry values was done at termination of the treatment.
Sacrifice of surviving animals and organ weight determination.
Gross pathological examination and histopathological examination when adverse effects were observed.

Statistics:

A statistical assessment of the results of the body weight, food consumption, parameters of haematology, blood coagulation and clinical biochemistry and absolute and relative organ weights was performed for each gender by comparing values of dosed with control animals using a one-way ANOVA and a post-hoc Dunnett Test. Statistical analysis of paired organs was performed on total weight of the particular paired organ. These statistics were performed with GraphPad Prism V.5.01 software (p<0.05 is considered as statistically significant).

Results and discussion

Effect levels

Dose descriptor:

NOEL

Effect level:

1 000 mg/kg bw/day (actual dose received)

Sex:

male/female

Basis for effect level:

other: no effects on reproductive organs were detected

Observed effects

For general toxicity and detailed descriprition see section 7.5.1 Repeated dose toxicity.
With respect of reproductive organs in male and female rats no adverse effects were observed in none of the treated animals.

Applicant's summary and conclusion

Executive summary:

In a subacute toxicity study according to OECD TG 407 ditolylether disulfonic acid disodium salt, isomer mixture dissolved in water was administered 7 days per week in graduated doses (100, 300, 1000 mg/kg bw/day) to 3 groups of male and 3 groups of female rats. Animals of an additional control group were handled identically (see also section 7.5.1 Repeated dose toxicity).

Based on the data referring to reproductive organs in treated male and female rats generated from this study, no significant toxicological effects of ditolylether disulfonic acid disodium salt, isomer mixture were found up to 1000 mg/kg bw/day. Therefore the NOEL (No Observed Effect Level) is considered to be 1000 mg/kg bw/day.