Sodium dimethyl 5-sulphonatoisophthalate

Repeated dose toxicity: inhalation

Administrative data

Endpoint:

short-term repeated dose toxicity: inhalation

Remarks:

Repeated Sublethal Testing

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1959

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1959

Report date:

1959

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Rats were exposed 4 h per day for 9 days within a 14-day period to a single concentration (32 mg/L) of the test substance (whole body exposure). The study predates OECD guidelines.

GLP compliance:

no

Remarks:

study was performed prior to implentation of GLP

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium dimethyl 5-sulphonatoisophthalate

EC Number:

223-578-8

EC Name:

Sodium dimethyl 5-sulphonatoisophthalate

Cas Number:

3965-55-7

Molecular formula:

C10H10O7S.Na

IUPAC Name:

sodium 3,5-bis(methoxycarbonyl)benzenesulfonate

Test material form:

not specified

Test animals

Species:

rat

Strain:

other: ChR-CD

Sex:

not specified

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

> 75 % of particles were < 3 µm in diam.

Analytical verification of doses or concentrations:

yes

Details on analytical verification of doses or concentrations:

no data

Duration of treatment / exposure:

4 hours exposures, 9 during 2-week period.

Frequency of treatment:

see above

Doses / concentrations

Dose / conc.:

32 mg/L air (analytical)

Remarks:

Basis:
analytical conc.

No. of animals per sex per dose:

6 animals per dose

Control animals:

no

Details on study design:

- Dose selection rationale: based on result of acute inhalation study

Positive control:

none

Examinations

Observations and examinations performed and frequency:

CLINICAL OBSERVATIONS: Yes

BODY WEIGHT: No data

FOOD CONSUMPTION: No data

WATER CONSUMPTION: No data

OPHTHALMOSCOPIC EXAMINATION: No data

HAEMATOLOGY and CLINICAL CHEMISTRY: No

URINALYSIS: No

NEUROBEHAVIOURAL EXAMINATION: No

Sacrifice and pathology:

GROSS PATHOLOGY: Yes (no further data)
HISTOPATHOLOGY: Yes (no further data)

Statistics:

none

Results and discussion

Results of examinations

Clinical signs:

effects observed, treatment-related

Description (incidence and severity):

discomfort

Mortality:

mortality observed, treatment-related

Description (incidence):

discomfort

Details on results:

Pathological Changes:
1 rat killed day of 9th treatment - slight emphysema
1 rat killed 11 days after 9th treatment - bronchopneumonia possibly aggravated by exposure

Effect levels

Key result

Dose descriptor:

conc. level:

Effect level:

ca. 32 mg/L air

Based on:

test mat.

Sex:

not specified

Basis for effect level:

other: Only one dose level tested; Discomfort; effects in lung noted in 2/6 animals (pulmonal irritation but no systemic effects).

Remarks on result:

other: Repeated inhalation of massive amounts of dust may be a source of pulmonary irritation.

Target system / organ toxicity

Key result

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

Repeated inhalation of an extremely high concentration of SIM-Ester in its dust form (32 mg/L) resulted in adverse effects in the respiratory tract.

Executive summary:

In a repeated dose inhalation toxicity study (Haskell Laboratory for Toxicology and Industrial Medicine, 1959) 6 ChR-CD rats were whole body exposed to SIM-Ester dust 4 hours per day for 9 days during a period of two weeks. The test concentration was 32 mg/L (+/- 20%); 75% of the particles had a diameter below or equal to 3 µm. Amimals showed discomfort. Treatment related effects were limited to a slight emphysema seen in one animal (sacrificed on the 9th treatment day) and bronchopneumonia observed in another animal (sacrificed 11 days after the 9th treatment). No further pathologcial changes were reported. The authors concluded that repeated inhalation of massive amouts of SIM-Ester in its dust form may be a source of pulmonary irritation. This is most likely due to the dust overload effect and not related to the intrinsic properties of the substance.