Alkylated Naphthalene Sulphonic Acid

Endpoint summary

Description of key information

The test substance was administered by gavage to 5 rats/sex at 2000 mg/kg bw. No mortality, no clinical signs, no effects on body weight and no macroscopic findings were seen. The LD50 is > 2000 mg/kg bw (PSL 2001).
A study on the analogue DNNSA showed an LD50 value of > 2500 mg/kg bw.
The test substance was applied dermally to 5 rabbits/sex at 2000 mg/kg bw. No mortality, no clinical signs, no effects on body weight and no macroscopic findings were seen. Erythema and oedema upto grade 2 were reported in all animals until 72 hours after application of the test substance. The LD50 is > 2000 mg/kg bw (PSL 2001)
A study on a formulation of the analogue DNNSA showed an LD50 value of > 1000 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:

April 3-17,2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study under GLP, test performed before withdrawal of the guideline in 2002

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

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: Ace Animals, Inc., Boyertown, PA
- Age at study initiation: 11-12 weeks
- Weight at study initiation: Males: 236-290 g; Females: 201-233 g
- Fasting period before study: yes 24.5 h before and 3 h after dosing
- Housing: individually
- Diet: Purina Rodent Chow #5012 ad libitum
- Water: Filtered tap water ad libitum:
- Acclimation period: 27 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-24°C
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE: none

MAXIMUM DOSE VOLUME APPLIED: 0.62 mL (< 1 ml/100g)

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males + 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
-BW on day 0, 7 and 14
-Clinical signs on day 1 (1 and 3 hours after dosing) and daily thereafter (included gross evaluation of skin and fur, eyes and mucous membranes,
respiratory, circulatory, autonomic and central nervous systems, motor activity and behavior pattern)
- Necropsy of survivors performed: yes, gross examination on day 14

Statistics:

NA

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

none observed

Body weight:

within normal ranges

Gross pathology:

no findings

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the test substance in rats is > 2000 mg/kg bw

Executive summary:

The test substance was administered by gavage to 5 rats/sex at 2000 mg/kg bw. No mortality, no clinical signs, no effects on body weight and no macroscopic findings were seen. The LD50 is > 2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

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:

April 5 - 19, 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: study according to the guideline under GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

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:

TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, MA 01004
- Age at study initiation: 13 weeks
- Weight at study initiation: males: 2316-2645 g; females: 2296-2586 g
- Fasting period before study: NA
- Housing: individually
- Diet: Pelleted Purina Rabbit Chow #5326 ad libitum
- Water Filtered tap water ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23°C
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 6X8 inches
- % coverage: 10%
- Type of wrap if used: occlusive (6-ply gauze pad wrapped with 3 inch Durapore tape)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with mineral oil, acetone and water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied : 2000 mg/kg bw

VEHICLE : none

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males + 5 females

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
-BW on day 0, 7 and 14
-Clinical signs on day 1 (1, 5 and 6 hours after application) and daily thereafter (included gross evaluation of skin and fur, eyes and mucous
membranes, respiratory, circulatory, autonomic and central nervous systems, motor activity and behavior pattern)
-Erythema and oedema at approximately 25 minutes (30-60 minutes after patch removal), 48 and 72 hours after application and on day 7 and 14
- Necropsy of survivors performed: yes, gross examination on day 14

Statistics:

NA

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

none seen

Body weight:

within normal ranges

Gross pathology:

no findings

Other findings:

erythema and oedema was seen in all animals (maximum grade 2) after 25 min and 24 and 72 hours. This effect was fully reversible on day 7 (only slight desquamation)

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the test substance is > 2000 mg/kg bw

Executive summary:

The test substance was applied dermally to 5 rabbits/sex at 2000 mg/kg bw. No mortality, no clinical signs, no effects on body weight and no macroscopic findings were seen. Erythema and oedema upto grade 2 were reported in all animals until 72 hours after application of the test substance. The LD50 is > 2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Justification for selection of acute toxicity – oral endpoint
key study performed according to the guideline under CLP

Justification for selection of acute toxicity – inhalation endpoint
The inhalation route is considered not relevant in view of the high viscosity and low vapour pressure of the test substance. The uses identified are not expected to lead to aerosol formation with droplets in the inhalable range.

Justification for selection of acute toxicity – dermal endpoint
key study performed according to the guideline under CLP

Justification for classification or non-classification

Based on the LD50 values derived, no classification according to CLP (Regulation EC No 1272/2008) or DSD (Directive 67/548/EEC). Given the high viscosity and the fact that the test substance is not a pure hydrocarbon, classification for aspiration hazards is not required. No specific target organ toxicity was observed in any of the acute studies and thus STOT single exposure classification is not required.