Reaction products of naphthalene, benzyl alcohol, sulphuric acid, formaldehyde and ammonia

Endpoint summary

Description of key information

Given a resulting LD50 of >5000 mg/kg following an acute toxicity experiment in Wistar rats, Aryl sulphonate condensate was concluded to be non-acutely toxic via the oral route. Hazard classification is not required (CLP Regulation (EC) No 1272/2008).

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:

June 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

yes

Remarks:

5000 mg/kg was selected as the highest dose and not 2000 mg/kg. In the 200 - 2000 mg/kg treatment groups, two male and two female rats were used rather than five of the same sex and individual animal results for these concentrations were not recorded.

Principles of method if other than guideline:

The test item was administered once by oral gavage following an overnight fast using a metal stomach tube attached to a 20 ml disposable syringe. Four groups of four albino Wister rats (two male and two female) were dosed with 250, 500, 1000, and 2000 mg/kg (48-hour range-finding study) and one group of ten albino Wistar rats (five male and five female) were dosed with 5000 mg/kg as part of the main 14-day experiment. Solutions of the test article were prepared in distilled water at a treatment volume of 10 ml/kg to give 25, 50, 100, 200, and 500 mg/ml.

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Wistar

Remarks:

Albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Bantin and Kingman Limited, Grimston, Aldbrough, Nr. Hull.
- Weight at study initiation: Males were within 163 - 172 g and females were within 121 - 136 g.
- Fasting period before study: An overnight 16 - 20 hour fast before treatment.
- Housing: Animals were caged in groups of two for the 250 - 2000 mg/kg treatments or five for the 5000 mg/kg treatment by sex and dose group in solid-bottomed plastic cages furnished wish softwood sawdust (Sawdust Marketing Company) which was replaced twice per week.
- Diet: Food supplied ad libitum (Rat and Mouse No. 1 Expanded Diet, BP Nutrition (UK) Limited, Stepfield, Witham, Essex).
- Water: Mains water was provided and dispensed from glass water bottles ad libitum. Clean and disinfected water bottles were provided once per week.
- Acclimation period: The animals were acclimatised to the laboratory environment for 6 days.
- Other: All animals were examined for signs of injury or ill-health.

ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 25 °C.
- Humidity: 40 - 60 %.
- Air changes: The single room housing the cages was air-conditioned.
- Photoperiod: A daily artificial lighting condition of 12 hours light (06:00 - 18:00) and 12 hours dark.

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25, 50, 100, 200, and 500 mg/ml.
- Amount of vehicle: Treatment volume of 10 ml/kg.

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg (solution concentration of 500 mg/ml).

Doses:

Range-finding study: 250, 500, 1000, and 2000 mg/kg.
Main experiment: 5000 mg/kg.

No. of animals per sex per dose:

Four animals (two male and two female) per dose level between 250 - 2000 mg/kg and ten animals (five male and five female) for dose level 5000 mg/kg.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 48 hours for the range-finding study and 14 days for the purpose of the main experiment.
- Frequency of observations: For the 200 - 2000 mg/kg dose groups, animals were frequently observed for mortality during the 48-hour period following treatment. For the higher dose group (5000 mg/kg), animals were observed for overt signs of toxicity and behavioural change at 1 and 4 hours after treatment and subsequently once daily for 14 days.
- Necropsy of survivors performed: Yes, all animals in the 5000 mg/kg dose group that survived to the end of the study were killed by exposure to high levels of carbon dioxide and subjected to a gross necropsy examination.
- Other examinations performed: Individual animal body weights for the 5000 mg/kg dose group were recorded the day before treatment, the day of treatment and at 2, 3, 8, and 14 days after treatment.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

All treated animals survived the experimental period.

Clinical signs:

other: No clinical signs of toxicity were noted on the day of dosing or during the 14-day observation period.

Gross pathology:

Nothing remarkable was noted in any of the organs examined.

Interpretation of results:

GHS criteria not met

Conclusions:

Aryl sulphonate condensate was found to have an acute oral LD50 of >5000 mg/kg and subsequently does not require classification as an acute oral toxin (CLP Regulation (EC) No 1272/2008).

Executive summary:

To determine the acute oral toxicity of Aryl sulphonate condensate, an experiment was performed using a protocol similar / equivalent to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method). The test item was administered once to male and female albino Wistar rats by oral gavage at dose levels of 250, 500, 1000, and 2000 mg/kg as part of a range-finding study and at 5000 mg/kg for the main test, with distilled water used as a vehicle (treatment volume of 10 ml/kg). Animals were observed for mortality over a 48-hour period in the range-finding study. Mortality, appearance, behaviour, general observations, and body weight were recorded for animals in the 5000 mg/kg dose group to evaluate potential adverse effects and at the end of the test these animals were subject to necropsy.

No mortality was recorded in the 48-hour and 14-day dose groups. In addition, no clinical signs of toxicity were observed, nor abnormal change to body weight or internal organ tissue following examination. An acute oral LD50 of >5000 mg/kg was determined for Aryl sulphonate condensate and subsequently, classification as an acute oral toxin is not required under CLP Regulation (EC) No 1272/2008.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw