Naphthalenesulfonic acid, di-C9-rich C8-10-branched alkyl derivs., barium salts

Endpoint summary

Description of key information

The oral LD50 is 1,750 mg/kg.
The dermal LD50 ~ 10,000 mg/kg.
The use as a lubricant additive is unlikely to result in significant human exposure to inhalable droplets. In addition, a 1 hour exposure at 21 mg/L did not cause toxic symptoms or death.

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:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study was conducted prior to GLP regulations but used methods generally consistent with accepted procedures. More animals were used than required by current protocols and a good dose-response and statistically valid LD50 value were obtained.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Rats derived from Royalhart Colony.
Rats were fasted 18 hours before dosing and then individually and singly dosed by gavage.

Doses:

2,3,4,5, and 6 ml/kg bw

No. of animals per sex per dose:

5 males
5 females

Control animals:

no

Details on study design:

Five groups of 5 male and 5 female rats, weighing 200-300 grams, were used in each of 5 treatment groups.

Statistics:

LD50 calculated by Litchfield-Wilcoxin Method of Probit Analysis

Preliminary study:

A separate study (T-399) was conducted earlier (July 10, 1978) with a single dose of 5 dose of 5 grams / kg bw.
10 male rats (207 - 294 grams) were used. 7 of 10 (70%) of the treated rats died.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 3.5 mL/kg bw

Based on:

test mat.

95% CL:

>= 2.8 - <= 4.3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 1 750 mg/kg bw

Based on:

act. ingr.

Mortality:

see attached table
Oral LD50 : 3.5 ml/kg 95% confidence limits 2.8-4.3 ml/kg

Clinical signs:

other: Not reported

Gross pathology:

see attached table

Group	Dose ml/kg-bw	Male	Female	% Mortality
1	2	0/5	2/5	20
2	3	1/5	2/5	30
3	4	3/5	3/5	60
4	5	2/5	4/5	60
5	6	5/5	4/5	90

 

Clinical Observation	2 mg/kg No. Animals	3 mg/kg No. Animals	4 mg/kg No. Animals	5 mg/kg No. Animals	6 mg/kg No. Animals
Discolored Spleen	1	1	1	2	5
Discolored Liver	1		3	3	8
GI Tract Hemorrhage		1
Ocular Hemorrhage			1	3	1
Subcutaneous Hemorrhage	1			1
Lung Hemorrhage	1	2	5	5	7
No. Animals Examined	10	10	10	10	10

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Oral LD50 = 3.5 ml/kg bw (as tested formulation)
Oral LD50 = 1750 mg/kg bw (based on 50% purity)

Executive summary:

Five male and 5 female rats were dosed with the test substance at 2, 3, 4, 5, and 6 ml/kg bw.

The calculated oral LD50 is 3.5 ml/kg bw.

The oral LD50 is 1750 mg/kg bw (based on 50% purity of formulation).

The following mortality was observed:

Group	Dose ml/kg-bw	Male	Female	% Mortality
1	2	0/5	2/5	20
2	3	1/5	2/5	30
3	4	3/5	3/5	60
4	5	2/5	4/5	60
5	6	5/5	4/5	90

 

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 750 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

10 000 mg/kg bw

Quality of whole database:

Two dermal studies were available in rabbits. Study dermal.001 (1981) used a dose of 1000 mg/kg and produced no mortality. Study dermal.002 (1978) used a dose of 10,000 mg/Kg in which 5/10 rabbits died. Together they show the NOEL was greater than 1000 mg/kg and that the LD50 is ~ 10,000 mg/kg on active ingredient basis. The 2 studies have consistent resutls and together form a quality database.

Additional information

Justification for selection of acute toxicity – oral endpoint
Study was conducted prior to GLP regulations but used methods generally consistent with accepted procedures. More animals were used than required by current protocols and a good dose-response and statistically valid LD50 value were obtained. The LD50 of 1750 is based on active ingredient composition of the formulation tested.

Justification for selection of acute toxicity – inhalation endpoint
The use as a lubricant additive is unlikely to result in significant human exposure to inhalable droplets.
An inhalation study is available that was conducted with a 1 hour exposure (4 hour exposure is required). This study showed no toxicity at an exposure of 21 mg/Liter (Acute Inhalation Study, Report T-378, June 1, 1978).

Justification for selection of acute toxicity – dermal endpoint
The study was not conducted to meet GLP regulations, however, the test followed standard guideline procedures (US Federal Hazardous Substances
Labeling Act (FHSLA) 16 CFR 1500). More animals were tested (10) than are used in current tests so the test result is statistically valid. Rabbit skin in this test was abraded in 5 rabbits which increases dermal penetration and increases exposure relative to current testing methods.

Justification for classification or non-classification

Based on data the substance is classifiable for acute oral toxicity Category 4 according to CLP. Annex VI CLP requires barium salts in general, not covered by an exemption, to be classified also for inhalative acute toxicity, Category 4. Despite the available data, that clearly indicate no need for classification, the classification harmful by the inhalation route is included in the proposal for C&L for this substance. No classification for acute dermal toxicity is required. Also, no classification for aspiration hazards is required, as the substance is not a hydrocarbon. Classification for STOT SE is also not required, as no such effects were seen in any of the studies. In conclusion the substance is classifiable for acute toxicity by oral and inhalation route Category 4 according to CLP (Regulation EC No 1272/2008).