Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts , overbased including distillates (petroleum), hydrotreated heavy paraffinic C10-C50

Endpoint summary

Description of key information

Acute mammalian toxicity in rats, exposed by the oral gavage, inhalation and dermal routes

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.

Key result

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:

GHS criteria not met

Conclusions:

No mortality has occured at doses of 5000 mg/kg bw. The study has therefore been completed as a limit test and the LD50 is considered to be more than 5000mg/kg

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:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

K2

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08th October 1986 - 22 October 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Qualifier:

according to guideline

Guideline:

EPA OPP 81-3 (Acute inhalation toxicity)

Deviations:

yes

Remarks:

male animals slightly younger than specified in the protocol

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:

TEST ANIMALS

- Source:
Charles River Breeding Laboratories, Inc. Kingston, New York 12484

- Age at study initiation:
nine to twelve weeks old

- Weight at study initiation:
194g to 232g.

- Fasting period before study:
Not applicable

- Housing:
Animals were doubly-housed i n suspended stainless steel wire mesh cages during the first week of the acclimation period and individually during the remainder of the acclimation period and all other non-exposure periods

- Diet:
ad libitum

- Water:
ad libitum

- Acclimation period:
eight days

ENVIRONMENTAL CONDITIONS

- Temperature:
67-76°F

- Humidity:
30-70%

- Photoperiod (hrs dark / hrs light):
twelve hours continuous light and twelve hours darkness

IN-LIFE DATES:
From: 08 October 1986 To: 22 October 1986

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:
Approximately 410 mls of test material was placed into a 500 ml Erlenmeyer flask and connected to an FMI fluid metering pump (Model #RPG-20) with a 1/4" piston, plus exposure chamber

- Exposure chamber volume:
approximately 100 litres

- Method of holding animals in test chamber:
Animals were i ndividual ly housed in a 100 liter Plexiglas exposure chamber.

- Source and rate of air:
House-supply air was delivered through 1/4" Tygonm tubing, a Nupro metering valve and a Union Carbide pressure gauge (at a constant backpressure of 25 pounds per square inch, psi) to a 0-20 lpm Dwyer flowmeter at a calibrated flow rate of 20.1 lpm into the air inlet of the atomizer to generate the aerosol.

- Method of conditioning air:
None described

- System of generating particulates:
Erlenmeyer flask and connected to an FMI fluid metering pump (Model #RPG-20) with a 1/4" piston

- Method of particle size determination:
Marple Personal Cascade Impactor (Westech IS Ltd, Beds., UK).

- Treatment of exhaust air:
None specified

- Temperature and humidity: An Airguide humidity indicator was used to continuously monitor relative humidity and a Taylor thermometer was used to continuously monitor air temperature in the exposure chamber. Recordings of temperature, relative humidity and air flow rate readings were made every 1/2 hour during exposure.

TEST ATMOSPHERE
- Brief description of analytical method used:
Samples for determination o f the exposure level were drawn from the exposure chamber using Whatman glass microfibre filter paper (Type GF/F, 3.7 cm) mounted in a Gelman gravimetric filter holder. Samples were withdrawn for 4 minutes at an airflow rate of 1 lpm, once per hour from the normal sampling portal and once during exposure from the distribution sampling portal.

- Samples taken from breathing zone:
Yes

VEHICLE
- Composition of vehicle (if applicable):
Not applicable

- Concentration of test material in vehicle:
Not applicable

- Justification of choice of vehicle:
Not applicable

- Lot/batch no. (if required):
Not applicable

- Purity: Not applicable

- MMAD (Mass median aerodynamic diameter:
9.93 µm

CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: Not applicable.

Analytical verification of test atmosphere concentrations:

no

Remarks:

Gravimetric only

Duration of exposure:

4 h

Concentrations:

Mean Maximum Attainable (mg/L) 1.9
Nomianl Concentration (mg/L) 41
Mean Mass Median Aerodynamic Diameter (µm) 4.2
Inhalable Fraction (% <10 µm) 93
Geometric Standard Deviation 1.9

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: Day 1 (Day of Exposure) All animals were observed individually, immediately prior to exposure, as a group at approximately fifteen-mi nute intervals during the first hour of exposure and hourly for the remainder of the exposure period. All animals were observed individually upon removal from the chamber (half-hour after exposure was completed) and hourly for two hours post-exposure. Detailed physical observations were recorded at each interval. Days 2 through 15 (Post-exposure) Detailed observations were recorded for animals once daily; viability was assessed twice daily.
Individual bodyweights Day 1 (immediately prior to exposure) and on Days 2, 3, 5, 8 and 15 (just prior to sacrifice).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs.
Postmortem: A complete gross postmortem examination was performed on all animals sacrificed a t the end of the 14-day post-exposure observation period. The gross postmortemexaminations included examination of the nasal passages, trachea, external surface, allorifices, the cranial cavity , carcass, the brain and spinal cord, the thoracic, abdominal and pelvic cavities and their viscera, and the cervical tissues and organs.
Method of Sacrifice: Exsanguination while under ether anesthesia.

Statistics:

Data evaluations included the relationship, if any, between the animals’ exposure to the test material and the incidence and severity of all abnormalities including behavioural and clinical observations, necropsy findings, bodyweight changes, mortality and any other toxicological effects. Using the mortality data obtained, an estimate of the acute inhalation median lethal concentration (LC50) of the test material was made.

Preliminary study:

Not applicable

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 1.9 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: CL not given

Mortality:

All animals survived the duration o f the study.

Clinical signs:

other: Observations noted during exposure included reduced activity, closed eyes and a few animals with labored breathing towards exposure completion. Signs exhibited by animals upon removal from the chamber and during the two-hour post-exposure observation peri

Body weight:

Test Week 1 body weights were slightly less than pretest values in some animals. This was considered a minimal response to exposure. Test Week 2
body weights were considered unremarkable.

Gross pathology:

No gross effects of the test material were observed.

Other findings:

Not applicable.

Interpretation of results:

GHS criteria not met

Conclusions:

Ten of ten CD (Sprague-Dawley derived) rats receiving a single four-hour exposure to 1.9 mg/l o f OS 80020 (product as manufactured diulted to 65% in mineral oil) as a maximum attainable respirable aerosol, survived until sacrifice on Day 15. Signs of treatment included reduced activity and labored breathing during the exposure. Signs of treatment such as secretory signs and matted coats persisted during the first week after exposure, but generally abated before the Day 15 sacrifice. A minimal, transient adverse effect upon body weight was produced by treatment. Otherwise bodyweight values were considered unremarkable. Gross postmortem observations were considered unremarkable.

Executive summary:

Introduction

A single four-hour whole-body inhalation exposure was performed for Lubrizol Corporation using CD (Sprague-Dawley derived) rats (5/sex) todetermine the acute inhalation toxicity of OS 80020 (product as manufactured diluted to 65% in mineral oil). The test substance was administered into the breathing zone of the animals as an aerosol on 8 October 1986.

Species and strain of the test animal, method and route of test substance administration and target exposure level were determined by the sponsor. The test procedures followed guidelines described in the Health Effects Test Guidelines; Office of Pesticides and Toxic Substances, United States Environmental Protection Agency (EPA), October 1984 and in the Pesticide Assessment Guidelines, Subdivision F; Hazard Evaluation: Human and DomesticAnimals; Office of Pesticide Programs, United States Environmental Protection Agency, Office of Pesticide and Toxic Substances, November 1982; Section 81 -3 "Acute Inhalation Toxicity Study". This study was conducted at Bio/dynamics, Inc., Mettlers Road, East Millstone, New Jersey 08873.

Methods

A group of ten CD (Sprague-Dawley Derived) train rats (five males and five females) was exposed to an aerosol. The animals were exposed for four hours using a whole body exposure system, followed by a fourteen day observation period.

ResultsThe mean achieved atmosphere concentration was as follows:

Atmosphere Concentration
Mean Maximum Attainable (mg/L)		Nominal (mg/L)
1.9		41

The characteristics of the achieved atmosphere were as follows:

Mean Maximum Attainable Atmosphere Concentration (mg/L)	Mean Mass Median Aerodynamic Diameter (µm)	Inhalable Fraction (% <10 µm)	Geometric Standard Deviation
1.9	4.2	93	1.9

The mortality data were summarised as follows:

Mean Maximum Attainable Atmosphere Concentration (mg/L)	Deaths
	Male	Female	Total
1.9	0/5	0/5	0/10

Clinical Observations

Observations noted during exposure included reduced activity, closed eyes and a few animals with labored breathing towards exposure completion. Signs exhibited by animals upon removal from the chamber and during the two-hour post-exposure observation period on Day 1 included secretory signs, some respiratory signs, hunched appearance and matted coats. During Test Week 1, test animals exhibited decreasing signs of treatment such as secretory signs and matted coat. These signs mostly abated by Day 8 and during Test Week 2 animals exhibited few continuing signs of treatment.

Bodyweight

Test Week 1 body weights were slightly less than pretest values in some animals. This was considered a minimal response to exposure. Test Week 2 body weights were considered unremarkable.

Necropsy

No gross effects of the test material were observed.

Conclusion Ten of ten CD (Sprague-Dawley derived) r a t s receiving a single four-hour exposure to 1.9 mg/l of OS 80020 as a maximum attainable respirable aerosol, survived until sacrifice on Day 15. Signs of treatment included reduced activity and labored breathing during the exposure. Signs of treatment such as secretory signs and matted coats persisted during the first week after exposure, but generally abated before the Day 15 sacrifice. A minimal, transient adverse effect upon body weight was produced by treatment. Otherwise bodyweight values were considered unremarkable. Gross post mortem observations were considered unremarkable.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

1.9 mg/m³ air

Quality of whole database:

K1

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:

Between 30 October 1986 and 13 November 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Qualifier:

according to guideline

Guideline:

other: 40 CFR, Section 163.81-2, Federal Register, August 22, 1978

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

The New Zealand White rabbit, weighing 2.0 to 3.0 kg, was used for this study. The animals were obtained from Buckshire, Corp., Perkasie PA 18944 (U.S.D.A. License (#23-BL).
The animals were individually housed and maintained in accordance with standards set forth in the Guide for the Care and Use of Laboratory Animals (DHEW Publication No. 80-23). The rabbits were acclimated to the laboratory for at least 5 days prior to dosing.
The animals were individually identified by an ear tag and each cage was identified with a cage card.
Husbandry Conditions:
Relative Humidity,%: 55 ± 25
Temperature: 60°F - 75°F
Light: 12 hour light/dark cycle
Diet: Wayne 15% Rabbit Ration and tap water were provided ad libitum. Based on our current knowledge, no contaminants are known to be in this diet or water which might be expected to interfere with the objectives of the study.
Caging: Stainless steel with elevated wire mesh flooring, 1 rabbit/cage.

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The Test Article was dosed as supplied, at a dose level of 4.0 g/kg

Duration of exposure:

24 hours

Doses:

4.0 gm /kg body weight

No. of animals per sex per dose:

5 male
5 female

Control animals:

not required

Details on study design:

The test article was dosed as supplied at a dose level of 4.0 g/kg.
A group of 10 rabbits (5 male & 5 female) with healthy intact skin was used. Approximately 24 hours before testing the fur was clipped from the backs of the test animals.
All rabbits were weighed and the correct amount of Test Article was applied to approximately 10% of the body surface on each animal. The treated area was covered with a large porous gauze patch and wrapped with an impervious material to ensure that the animal did not ingest the Test Article. The dressings were removed after 24 hours and any excess material removed, where practical, using water or an appropriate solvent.
The animals were observed for a 14 day period for signs of toxicity (systemic and topical) and for mortalities. Animals were observed frequently during the first day of dosing, and twice per day (morning and afternoon) on weekdays. On weekends and holidays, animals were observed once per day. Individual weights were recorded on the day of dosing, weekly thereafter, and prior to sacrifice. The animals were euthanized using T-61 at the conclusion of the observation period. Gross necropsies were performed on all animals.

Statistics:

No statistical analysis was performed.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 95% confidence limits not reported.

Mortality:

See Table 1 (attachment 1) for individual mortality data
One female animal died during the study

Clinical signs:

other: See Table 2 (attachment 2) for Observations data

Gross pathology:

See Table 2 (attachment 2) for Pathology data

Other findings:

None.

Interpretation of results:

GHS criteria not met

Conclusions:

The Test Article when dosed as supplied and studied in 5 male and 5 female albino rabbits, appears to have an acute dermal LD50 greater than 4.0 g/kg.

Executive summary:

Introduction: To determine the acute dermal toxicity of the Test Article in rabbits. Method: The Test Article was dosed as supplied, at a dose level of 4.0 g/kg. A group of 10 rabbits (5 male & 5 female) with healthy intact skin was used. The animals were observed for a 14 day period for signs of toxicity (systemic and topical) and for mortalities. Conclusion: Test Article when dosed as supplied appears to have an acute dermal LD50 greater than 4.0 g/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

K1

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

Data from several studies are available for this endpoint.  The lowest dose tested as 5000mg/l and all data available demonstrate a lack of toxicity at or below this dose level.  This is concentration is therefore assigned as a limit for oral toxicity

Justification for selection of acute toxicity – inhalation endpoint

Exposure to the test substance was at the highest attainable dose.  No toxic effects were observed at the maximum dose.

Justification for selection of acute toxicity – dermal endpoint

Several study data endpoints are available to assess the dermal toxicity.  All data demonstrate a complete absence of toxic effects due to exposure.

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.