Benzene, mono-C10-14-alkyl derivs., fractionation bottoms, intermediate cut, sulfonated, sodium salts

Endpoint summary

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted according to OECD Guidelines and to GLP, but not fully reported.

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

None provided in study report.

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

Animals were observed for 14 days following administration of the test substance.
Bodyweights were recorded on the day of dosing and at 2, 7 and 14 days after dosing.

Necropsy of survivors performed: yes

Clinical signs were observed and bodyweights measured.

Statistics:

No mortality occurred. Use of statistics not indicated.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000

Remarks on result:

other: 95% CL not indicated. LD50 is greater than 5000 mg/kg bw.

Mortality:

Mortality did not occur in treated animals.

Clinical signs:

other: Diarrhoea and reduced food intake were observed in one treated female on day one of dosing.

Gross pathology:

No treatment related effects were observed on necropsy.

Table 2: Number of animals dead [and with evident toxicity] [and time range within which mortality occurred]

 

Dose (mg/kg bw)	Mortality (# dead/total)			Time range of deaths (hours)	Number with evident toxicity (#/total)
	Male	Female	Combined		Male	Female	Combined
Control	0/5	0/5	0/10		0/5	0/5	0/10
5000	0/5	0/5	0/10		0/5	1/5	0/10

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Mortality did not occur at doses of 5000 mg/kg bw, therefore, and LD50 was not determined.

Executive summary:

In an acute oral toxicity study, groups of Sprague-Dawley rats (5/sex) were given a single oral dose of sodium 4-icosylbenzenesulfonate at doses of  0 or 5000  mg/kg bw and observed for 14 days.

 

No mortality occurred in this limit test, therefore an LD50 has not been determined.

This acute oral study is classified as acceptable. It satisfies the guideline requirement for an acute oral study OECD 401 in the rat. 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted to OECD guidelines and GLP, but not fully reported.

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION

- Exposure apparatus: Pressure spray

- Exposure chamber volume: 100 l

- System of generating particulates/aerosols: pressure spray

- Method of particle size determination: multi stage cascade impactor








TEST ATMOSPHERE

- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 4.2 microns S.d. 1.9

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

>= 4 h

Concentrations:

1.9 mg/l

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 and weighing: bodyweight determined on day 1, 2, 3, 5, 8 and 15

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight

Statistics:

Statistical method not stated.

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 1.9 mg/L air (analytical)

Exp. duration:

4 h

Remarks on result:

other: 95% CL not indicated.

Mortality:

Mortality did not occur in treated animals.

Clinical signs:

other: Clinical signs of toxicity included reduced activity, matted coat and closed eyes. On day 1, lacrimation, nasal discharge, salivation, rales, matted coat, hunched appearance, soft stools and closed eyes were observed in treated animals. These clinical sig

Body weight:

Several animals had very slight decreases in bodyweight on day 2, but recovered by day 5.

Gross pathology:

No treatment related effects were observed on necropsy.

Table 2: Concentrations, exposure conditions and number of evident toxicity per animals treated

 

Nominal Conc. (mg/L)	Analytical Conc. (mg/L)	MMAD µm	GSD	Number with evident toxicity (#/total)
				Males	Females	Combined
	1.9	4.2	1.9	5/5	5/5	10/10

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Mortality did not occur at doses of 1.9 mg/l, therefore, an LC50 cannot be determined.

Executive summary:

In an acute inhalation toxicity study, groups of young adult Sprague Dawley rats (5/sex) were exposed by inhalation route for 4 hours via whole body exposure to petroleum derived calcium salts at concentrations of 1.9  mg/L. Animals then were observed for 14 days.

No mortality occurred in this limit test, therefore an LC50 has not been determined. This acute inhalation study is classified as acceptable. It satisfies the guideline requirement for an acute inhalation study in the rat.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating conc.

Value:

1 900 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:

October 13, 1997 - February 5, 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: No report on this study was provided to WRc, therefore this data has not been reviewed. All data provided in this study record was entered by the data owner.

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

See attached study report for details

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

See attached study report for details

Duration of exposure:

1, 2.5, 4 hours, and 14 day observations. See attached study report for details.

Doses:

5,000 mg/kg bw (single dose)

No. of animals per sex per dose:

5 males/ 5 females per single dose level

Control animals:

not required

Details on study design:

See attached study report for details

Statistics:

None required for study

Preliminary study:

LD50 > 5000 mg/kg bw

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No deaths occurred during the course of the study

Clinical signs:

other: Test material produced moderate to severe dermal irritation

Gross pathology:

See attached study report for details

Other findings:

See attached study report for details

See attached study report for details

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

Estimated dermal LD50 for males and females is > 5,000 mg/kg bw

Executive summary:

See attached study report for details

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Additional information

During exposure of the substance by the oral, dermal and inhalation routes only a minor incidence of mortality

was observed and never at a rate considered to be significant when dosing levels at or below the volumes

specified above. Where significant mortality has been observed, this was observed at dose levels significantly

higher than those specified above. The limit values expressed above are, therefore, considered appropriate.

Justification for selection of acute toxicity – oral endpoint

Mortality did not occur at doses of 5000 mg/kg bw, therefore, and LD50 was not determined.

Justification for selection of acute toxicity – inhalation endpoint

Mortality did not occur at doses of 1.9 mg/l, therefore, an LC50 cannot be determined.

Justification for selection of acute toxicity – dermal endpoint

Mortality did not occur at doses of 5000 mg/kg bw, therefore an LD50 was not determined.

Justification for classification or non-classification

As not significant mortality has been observed at the limit values expressed above, the substance is considered

to be not classified as acutely toxic.