Dinonylnaphthalenedisulphonic acid

Endpoint summary

Description of key information

Groups of rats (5/sex/dose) received a single dose of the test substance at 2000, 3000, 4000, 4500 and 5000 mg/kg bw (PSL 1978). In all groups mortality was reported. Necropsy showed degeneration and necrosis of the stomach as well as liver discoloration in several dead rats. The LD50 is 2035 mg/kg bw.
In a very limited reported inhalation study the LD50 found in rats  was > 110 mg/L (PSL 1978)
Rabbits (5/sex) were dermally exposed to the test substance for 24 hours (PSL 1977). No effects other than slight erythema and well defined oedema (not observed after day 9) were reported. Body weight gain was considered normal. Necropsy did not reveal any findings. The LD50 is > 1100 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:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: non GLP study with limited information on test design and results. The study allows a conclusion on the height of the LD50. The information in the report is limited to the information in the summary.

Qualifier:

no guideline followed

Principles of method if other than guideline:

method seems similar to OECD 401

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 200-300 g
- Fasting period before study: 18 hours
- Housing: individually
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data:
- Photoperiod (hrs dark / hrs light): no data

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw

Doses:

2000, 3000, 4000, 4500 and 5000 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: no data
- Necropsy of survivors performed: no, only on decendents
- Other examinations performed: clinical signs

Statistics:

Litchfield-Wilcoxin Probit Analysis

Sex:

male/female

Dose descriptor:

LD50

Effect level:

3 700 mg/kg bw

Based on:

test mat.

95% CL:

>= 3 080 - <= 4 440

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 035 mg/kg bw

Based on:

act. ingr.

95% CL:

>= 1 694 - <= 2 442

Mortality:

1 male + 1 female at 2000 mg/kg bw
2 males + 1 female at 3000 mg/kg bw
2 males + 3 females at 4000 mg/kg bw
1 male + 5 females at 4500 mg/kg bw
4 males + 4 females at 5000 mg/kg bw

Clinical signs:

none

Body weight:

no data

Gross pathology:

degeneration and necrosis of the stomach; liver discoloration in several dead rats

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

tance is 2035 mg/kg bw

Executive summary:

Groups of rats (5/sex/dose) received a single dose of the test substance at 2000, 3000, 4000, 4500 and 5000 mg/kg bw. In all groups mortality was reported. Necropsy showed degeneration and necrosis of the stomach as well as liver discoloration in several dead rats. The LD50 is 2035 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

2 035 mg/kg bw

Quality of whole database:

test on formulation

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1978

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Limited study report (non-GLP), exposure for 1 hour, very limited data on test conditions. The information in the report is limited to the information in the summary.

Qualifier:

according to guideline

Guideline:

other: FHSLA, CFR, Title.21, para. 191.10

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: males: 240-290 g; females 219-250 g
- Housing: 5 animals/ cage
- Diet/ water: no data

ENVIRONMENTAL CONDITIONS: no data

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

not specified

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION: spray was introduced into the chamber via a nebulizer, was circulated and was directed away from the animals.

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

1 h

Concentrations:

200 mg/L (nominal)

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: not indicated
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

NA

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 200 mg/L air (nominal)

Based on:

test mat.

Exp. duration:

1 h

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 110 mg/L air (nominal)

Based on:

act. ingr.

Exp. duration:

1 h

Mortality:

none

Clinical signs:

other: none reported

Body weight:

no data

Gross pathology:

no findings

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The 1-h LC50 of the test substance is > 110 mg/L

Executive summary:

Rats (5/sex) were exposed to an aerosol of 110 mg/L of the test substance for one hour. No mortality occurred during the 14 -day observation period. No effects on clinical behaviour or findings at necropsy. Therefore the LC50 is > 110 mg/L

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

test on formulation

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:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: study similar to the guideline (OECD 402), but non-GLP and with limited information on the conditions of performance. The information in the report is limited to the information in the summary.

Qualifier:

according to guideline

Guideline:

other: Federal Hazardous Sub­ stances Act (1973)

GLP compliance:

no

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: no data (from stock)
- Age at study initiation: mature
- Weight at study initiation:2045-2810 g
- Housing: individually
- Diet: Purina Rabbit Chow ad libitum
- Water: ad libitum
- Acclimation period: not indicated

ENVIRONMENTAL CONDITIONS: no data

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: not indicated
- Type of wrap if used: occlusive, rubber dam

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 mL
- Concentration (if solution): 55%

Duration of exposure:

24 hours

Doses:

2000 mg/kg

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: daily; weighing at start and on day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight

Statistics:

NA

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 100 mg/kg bw

Based on:

act. ingr.

Mortality:

none

Clinical signs:

slight erythema and well defined oedema until day 9, thereafter no findings

Body weight:

bodyweight gain within expected ranges

Gross pathology:

no findings

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the test substance is > 1100 mg/kg bw

Executive summary:

Rabbits (5/sex) were dermally exposed to the test substance for 24 hours. No effects other than slight erythema and well defined oedema (not observed after day 9) were reported. Body weight gain was considered normal. Necropsy did not reveal any findings. The LD50 is > 1100 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

1 100 mg/kg bw

Quality of whole database:

test on formulation

Additional information

All studies are performed on formulations. This lowers the reliability. The results are however indicative for a low acute toxicity via the oral, dermal and inhalation route. The main effects reported are related to local irritation.

Justification for selection of acute toxicity – oral endpoint
Study similar to the guideline. The doses tested ranged from 2000-5000 mg/kg bw. The LD50 value is corrected for purity.

Justification for selection of acute toxicity – inhalation endpoint
the study is indicative for low toxicity.

Justification for selection of acute toxicity – dermal endpoint
Study similar to the guideline. Limit test with formulation at 2000 mg/kg bw. The LD50 value is corrected for purity.

Justification for classification or non-classification

Based on findings in acute oral, dermal and inhalation studies with the substance it can be concluded that no classification for acute toxicity by oral, dermal or inhalation route is required according to CLP (Regulation EC No 1272/2008). Given the fact that the 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.