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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Acute toxicity testing (OECD 401) of Naphthalenesulfonic acid, methyl, butyl, sodium salt (ANS B) resulted to an Oral LD50 around 1500mg/ 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:
1978-11-15 till 1978-12-05
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
Performed before GLP
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Limited reporting.
- 1 sex.
- Acclimation period and housing conditions are unknown.
GLP compliance:
not specified
Remarks:
Before GLP
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
Commercial product.
Species:
rat
Strain:
other: Sherman - Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Albino rats of the Sherman-Wistar strain
- Weight at study initiation: weighing between 200 and 300 gm
- Fasting period before study: 24 hours prior to dosing
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: a 20% w/v suspension in water (200 mg/ml)

MAXIMUM DOSE VOLUME APPLIED: 16 ml/kg
Doses:
Dosage levels:
0,2 gm/kg
0,4 gm/kg
0,8 gm/kg
1,6 gm/kg
3,2 gm/kg
No. of animals per sex per dose:
5 male rats per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Weighing: Prior to dosing and final weight
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight.
Sex:
male
Dose descriptor:
LD50
Remarks:
Based on interpolation to 50% mortality between 800 mg/kg bw (0% mortality) and 1600 mg/kg bw (60% mortality)
Effect level:
ca. 1 500 mg/kg bw
Based on:
test mat.
Mortality:
Dose level 1.6 gm/kg 3 animals died.
Dose level 3.2 gm/kg 5 animals died.
Clinical signs:
other: Dose level 0.2 gm/kg and 0.4 gm/kg animals were slightly lethargic (normal after 24 hours). Dose level 0.8 gm/kg animals were depressed (normal after 24 hours). Dose level 1.6 gm/kg animals were depressed and exhibited shallow respiration after 1 hour. Th
Gross pathology:
Gross pathologic examination revealed nothing remarkble in the surviving animals sacrified at the conclusion of the study.
Some Hemorrhaging of the upper G.I. tract was evident in the animlas that died.

Concentration: 200 mg/ml

Dosage Level

gm/kg

Number of Animals Dosed

Mortalities

Days

Total Dead

14 Days

Total Survived

14 Days

Initial Weight

gm

Final Weight

gm

1

2

3

4

5

6

7

8

9

10

11

12

13

14

0.2

5

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

5

240

280

0.4

5

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

5

215

250

0.8

5

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

5

260

280

1.6

5

2

1

0

0

0

0

0

0

0

0

0

0

0

0

3

2

240

255

3.2

5

5

-

-

-

-

-

-

-

-

-

-

-

-

-

5

0

235

-

Based on the results LD50 is around 1.5 gm/kg.

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Migrated information
Conclusions:
The subject material when studied in male albino rats has an acute oral LD50 of around 1500 mg/kg bw.
Executive summary:

There was limited reporting.

The study was performed with similarities to OECD Guideline 401 (Acute Oral Toxicity), but not according to GLP standards.

The test material, Morwet B, was evaluated for its acute oral toxicity potential in albino rats when administered as gavage doses at levels of 0.2, 0.4, 0.8, 1.6 and 3.2 gm/kg to males. No mortality occurred in animals dosed at the 0.2, 0.4 and 0.8 gm/kg level. At 1.6 g/kg bw 3/5 animals died between 8 and 30 hours, and at 3.2 g/kg bw all 5 animals died in less than 2 hours.

Clinical signs of toxicity included shallow respiration and depression. Gross pathologic examination revealed nothing remarkable in the surviving animals sacrificed at the conclusion of the 14 -day observation period. Some haemorrhaging of the upper G.I. tract was evident in the animals that died.

Conclusions: The LD50 is about 1500 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 500 mg/kg bw
Quality of whole database:
Older, pre-GLP, guideline study without detailed documentation. Results are sufficient for classification purposes.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Oral:

Naphthalenesulfonic acid, methyl, butyl, sodium salt (ANS B)(C7-alkyl naphthalene sulfonate) wasevaluated for its acute oral toxicity potential (OECD 401) in albino rats. Test substance was administered by gavage at doses at levels of 200, 400, 800, 1600 and 3200 mg/kg bw to males. No mortality occurred in animals dosed up to the 800 mg/kg bw level. At 11600 mg/kg bw, 3/5 animals died between 8 and 30 hours, and at 3.2 g/kg bw all 5 animals died in less than 2 hours.

Clinical signs of toxicity included shallow respiration and depression. Gross pathologic examination revealed nothing remarkable in the surviving animals sacrificed at the conclusion of the 14-day observation period. Some haemorrhaging of the upper G.I. tract was evident in the animals that died.

Conclusions: The LD50 is about 1500 mg/kg bw.

 

The low acute toxicity by oral route is further confirmed in comparableNASproducts:

Various reports onthe ANS N products with high and low nonene substituted show comparable, relatively low acute toxicity. For purpose of classification, these studies point at an LD50 in range 2000-5000 for the pure substance. In an OECD 423 study on ANS IP, the dose level of 2000 mg/kg resulted to the death of all 3 animals, whereas no mortality was seen at 300 mg/kg. The resulting LD50 cut-off value is 500 mg/kg bw looks to indicate a somewhat higher toxicity, but basically the results are agreement with the ANS B results.

(See also chapter 13 for support for read-across within the category of Alkyl Naphthalene Sulfonates (ANS))

 

Dermal:

Acute and repeated dose testing via oral route on ANS IP show that C7-alkyl naphthalene sulfonate is of relative low systemic toxicity.Although the acute testing with ANS IP resulted to a LD50 cut-off value of 500 mg/kg, lethality was only seen following 2000 mg/kg, and necropsy of dead animals revealed blood in parts of the gastrointestinal tract, suggestive for local effects rather than systemic toxicity. This is confirmed in the repeated dose toxicity study where some mortality was seen following dosing at 700 mg/kg bw where the effects in the stomach (ulceration, erosion) might have contributed to the morbidity. Also the NOAEL is based on local effects, and close examination shows that the only effects observed at 200 mg/kg are a slight lower BW compared to control (-6%) in males, and an increased combined effects in stomach upon histopathological examinations in males. Also should be considered that C7 Naphthalene Sulfonate is not expected to easily pass the skin in view of its ionised form at physiological conditions, and as the substance is irritating to skin, and effects will be characterized by irritation rather than systemic toxicity.

 

The product itself is a powder and is only applied industrially in formulation steps involving high control of exposures with the application of PPE, especially considering that the substance is classified as irritating to the skin. Also the indicated end use only involves professional applications. As the substance is irritating to skin, and is of relatively low acute toxicity, and in practice dermal absorption from a dry powder is limited, further testing for acute toxicity via the skin is not considered to bring more relevant hazard information.

 

The comparable C10-13-alkyl naphthalene sulfonatealso showed low acute dermal toxicity. However, contrary to C7-alkyl naphthalene sulfonate, it was found to be corrosive to the skin, and dermal testingresulted to desquamation, fissuring, eschar formation and exfoliation. No mortality however occurred at 2000 mg/kg bw level.

 

Inhalation:

Testing of C7-alkyl naphthalene sulfonate for acute inhalation toxicity is not appropriate. The vapour pressure of ANS IP was determined to be 1.7 × 10-4Pa at 25 °C. Due to the very low vapour pressure inhalation of vapours leading to irritation of airways will not occur.Also the particle size is also mostly above respiratory size with aD50of 20.6 µm. The product itself is only applied industrially in formulation steps involving high control of exposures.Also the indicated end use only involves professional applications. Testing for acute toxicity by inhalation route is therefore generally not needed according to REACH regulation (EC) 1907/2006 (Annex VIII, point 8.5, column 2).

Furthermore, testing would also not be justified because of animal welfare reasons based on severe effects especially on mucosal epithelium. C7-alkyl naphthalene sulfonatehas proven to be irritating to skin showing low to no recovery, cat.1 damaging to the eyes and showing irritating and corrosive potential as based on local effects in stomach following acute and repeated oral,whereas otherwise systemic toxicity is low.

Justification for classification or non-classification

The results from the acute oral toxicity study resulted to an LD50 of about 1500 mg/kg bg bw, requiring CLP classification to Category 4, H302: Harmful if swallowed.

No actual testing for dermal toxicity is performed, but considering general systemic toxicity following oral route, where effects are characterised by local effects on gastro-intestinal system, and further expected limited dermal absorption (compared to oral)in view of its ionised form at physiological conditions,and in practice dermal absorption from a dry powder is limited, systemic toxicity via dermal route is not expected, and further testing for acute toxicity via the skin is not considered to bring more relevant hazard information.

 

Based on its physical appearance as solid there is no need for classification for aspiration hazard.