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Administrative data

Description of key information

LD50 (acute oral, rat) > 2000 mg/kg bw 
LC50 (inhalation, rat) > 32 mg/L 
LD50 (acute dermal, rat) > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1959
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scinetifically valid study without detailed documentation
Qualifier:
no guideline followed
Principles of method if other than guideline:
In this study predating the implementation of OECD guidelines seven dose levels were tested. One rat per dose was used, the observation time was 10-12 days. Clinical signs were examined, macroscopical examination at necropsy was performed.
GLP compliance:
no
Remarks:
study performed prior to implementation of GLP
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: ChR-CD
Sex:
not specified
Route of administration:
oral: gavage
Vehicle:
other: 30% susp. in 1% aqueous gum guar
Doses:
1000, 1500, 2250, 3400, 5000, 7500 and 11000 mg/kg bw.
Doses from 1000 to 5000 mg/kg bw were given as a single dose, whereas 7500 and 11000 mg/kg bw were given as 2 doses within 1 hr.
No. of animals per sex per dose:
1 animal per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 10-12 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Sex:
not specified
Dose descriptor:
LD0
Effect level:
11 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality
Clinical signs:
other: Diarrhea, white precipitate in urine and feces, discomfort, weight loss in some cases. Minimal effects at 3400 mg/kg bw and less.
Gross pathology:
None attributable to treatment found 10-12 days after exposure.
Conclusions:
Under the conditions of the present study the approximate lethal dose (LDLo) was > 11000 mg/kg.
Executive summary:

In an acute oral toxicity study (Haskell Laboratory for Toxicology and Industrial Medicine, 1959, non-GLP) rats (1/dose) were treated orally with Sodium Sulfo Dimethylisophtalate in concentrations of 7500, 5000, 3400, 2250, 1500 and 1000 mg/kg by a single dose. Furthermore, 11000 and 7500 mg/kg were given in 2 doses within one hour. Diarrhea, white precipitate in urine and feces, discomfort, wt. loss in some cases were observed. Effects were minimal at 3400 mg/kg and less. No mortility occurred leading to an approximate lethal dose (LDLo) of > 11000 mg/kg.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
11 000 mg/kg bw

Acute toxicity: via inhalation route

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Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1959
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically valid study without detailed documentation
Qualifier:
no guideline followed
Principles of method if other than guideline:
Study predates OECD guidelines. However, it follows the principles of a OECD guideline 403 limit test.
GLP compliance:
no
Remarks:
Study performed prior to implementation of GLP
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: ChR-CD
Route of administration:
inhalation: dust
Type of inhalation exposure:
not specified
Details on inhalation exposure:
> 75 % of particles were < 3µm in diam.
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
32 mg/lit +/- 20 %
No. of animals per sex per dose:
2 animals per dose
Details on study design:
- Observation period: at least 9 days
- Necropsy of survivors performed: yes
Sex:
not specified
Dose descriptor:
LC0
Effect level:
>= 32 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Mortality:
no mortality
Clinical signs:
other: Discomfort during exposure
Body weight:
no data
Gross pathology:
None of the pathological changes attributable to treatment found 9 days after exposure
Conclusions:
Under the conditions of the present study the approximate lethal concentration is > 32 mg/L.
Executive summary:

In an acute inhalation toxicity study ( Haskell Laboratory for Toxicology and Industrial Medicine, 1959, non-GLP) two rats were treated with Sodium Sulfo Dimethylisophtalate dust in concentrations of 32 mg/L +/- 20 % for 4 hours by inhalation. More than 75 % of the dusts particles had a size < 3µm in diameter. As clinical signs discomfort during exposure were noted. Mortality did not occur within the 9 -day observation period. At nercopsy none of the pathological changes were attributable to treatment. The results of the study indicate a LC0 of > 32 mg/L.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating conc.
Value:
32 000 mg/m³ air

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012-05-22 to 2012-06-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Toxi-Coop Zrt. 1103 Budapest, Cserkesz u. 90.
- Age at study initiation: Young adult rats, females were nulliparous and non-pregnant
- Weight at study initiation: 269-289 g (male); 255-267 g (female)
- Housing: during acclimatisation: 3 animals/sex/cage; during the study: animals were housed individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 19 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 - 70 %
- Air changes: 8-12 air exchanges/hour by central air-condition system.
- Photoperiod: Artificial light, from 6 am. to 6 pm.
Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: back of animals
- % coverage: least 10 % of the total body surface area
- Type of wrap if used: semi-occlusive plastic wrap

REMOVAL OF TEST SUBSTANCE
- At the end of the exposure period, residual test item was removed, using body temperature water.
- Time after start of exposure: 24 hours

TEST MATERIAL
- For solids, paste formed: The solid test item was moistened sufficiently with water
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations:
MORTALITY
twice daily
CLINICAL OBSERVATION
Animals were observed individually 1 h and 5 h after dosing, and once each day for 14 days thereafter.
BODY WEIGHT
On day 0 (shortly before the treatment), on day 7 and on day 15 (with a precision of 1 g in main study).
- Pathology: All animals were subjected to gross pathology.
Statistics:
No statistics were performed.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality
Clinical signs:
other: No behavioural changes or general systemic toxic signs were noted during the study. Similarly, no any local symptoms (dermal irritation) were observed on the treated skin of animals as redness and oedema.
Gross pathology:
No macroscopic alterations due to the systemic toxic effects of the test item were found.
Conclusions:
The obtained acute dermal LD50 value was greater than 2000 mg/kg bw in male and female Crl:(WI)BR rats.
Executive summary:

In an acute dermal toxicity study ( Toxi-Coop Zrt., 2012, OECD 402, GLP compliance) a single group of male and female animals (n=5 animals/sex) was exposed to Sodium dimethyl 5-sulphonatoisophthalate (SIM-Ester) at 2000 mg/kg bw by dermal route. The test item was applied in its original form and left in contact with the skin for 24 hours, followed by a 14-day observation period. No mortality occurred during the study. Neither male nor female animals treated at 2000 mg/kg bw showed behavioural changes and no systemic toxic signs were noted during the study. The test item did not cause dermal irritation symptoms as erythema, oedema or other signs. One female animal did not gain weight during the study period. As the body weight development of all other animals was not impaired, a test item related effect is unlikely. No macroscopic alterations of organs and tissues referred to the systemic toxic effect of the test item were seen during the necropsy. In conclusion, in this acute dermal toxicity study with SIM-Ester, the obtained acute dermal LD50 value was greater than 2000 mg/kg bw in male and female Crl:(WI)BR rats.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Additional information

Oral

In an acute oral toxicity study (Haskell Laboratory for Toxicology and Industrial Medicine (a), 1959, non-GLP) rats (1/dose) were treated orally with Sodium Sulfo Dimethylisophtalate in concentrations of 7500, 5000, 3400, 2250, 1500 and 1000 mg/kg bw by a single dose. Furthermore, 11000 and 7500 mg/kg bw were given in 2 doses within one hour. Diarrhea, white precipitate in urine and feces, discomfort, weight loss in some cases were observed. Effects were minimal at 3400 mg/kg bw and less. No mortility occurred even at the highest test dose of 11000 mg/kg bw. No pathological changes attributable to treatment were found at necropsy which was performed 10 to 12 days after exposure. Based on these results, it can be reliably concluded that the LD50 is above the regulatory threshold of 2000 mg/kg bw.

Inhalation

In an acute inhalation toxicity study ( Haskell Laboratory for Toxicology and Industrial Medicine (b), 1959, non-GLP) two rats were treated with Sodium Sulfo Dimethylisophtalate dust in concentrations of 32 mg/L +/- 20 % for 4 hours by inhalation. More than 75 % of the dusts particles had a size < 3µm in diameter. As clinical signs discomfort during exposure were noted. Mortality did not occur within the 9 -day observation period. At nercopsy none of the pathological changes were attributable to treatment. The results of the study indicate a LC0 of >32 mg/L.

Dermal

In an acute dermal toxicity study ( Toxi-Coop Zrt. (b) 2012, OECD 402, GLP compliance) a single group of male and female animals (n=5 animals/sex) was exposed to Sodium dimethyl 5-sulphonatoisophthalate (SIM-Ester) at 2000 mg/kg bw by dermal route. The test item was applied in its original form and left in contact with the skin for 24 hours, followed by a 14-day observation period. No mortality occurred during the study. Neither male nor female animals treated at 2000 mg/kg bw showed behavioural changes and no systemic toxic signs were noted during the study. The test item did not cause dermal irritation symptoms as erythema, oedema or other signs. One female animal did not gain weight during the study period. As the body weight development of all other animals was not impaired, a test item related effect is unlikely. No macroscopic alterations of organs and tissues referred to the systemic toxic effect of the test item were seen during the necropsy. In conclusion, in this acute dermal toxicity study with SIM-Ester, the obtained acute dermal LD50 value was greater than 2000 mg/kg bw in male and female Crl:(WI)BR rats.


Justification for selection of acute toxicity – oral endpoint
reliable study

Justification for selection of acute toxicity – inhalation endpoint
reliable study

Justification for selection of acute toxicity – dermal endpoint
Well documented and reliable study.

Justification for classification or non-classification

Based on the results obtained in the acute toxicity tests, Sodium dimethyl 5-sulphonatoisophthalate (SIM-Ester) is not subject to classification for acute toxicity according to Directive 67/548/EEC and according to Regulation (EC) No 1272/2008.