Registration Dossier

Administrative data

Description of key information

Oral: The acute oral median lethal dose (LD50) of the test material in the rat was greater than 5000 mg/kg bodyweight.

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:
1977-03-14 to 1977-04-04
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
according to
Guideline:
other: US Federal Hazardous Substances Labelling Act
Deviations:
not applicable
Principles of method if other than guideline:
A group of 30 albino male and female rats, fasted for 24-hours were assigned to various dose levels at random. The product was placed in a glass syringe and introduced into the stomach through the oesophagus using a stainless steel catheter.
Animals on the same dose were placed in a common cage with free access to food and water. The animals were observed daily for a two week period. No post mortem, or histopathology examinations were performed.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
No information provided on test animals
Animals housed in common cage after dosing. (5 per cage)
Free access to food and water.
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The product was placed in a glass syringe and introduced into the stomach through the oesophagus using a stainless steel catheter.
Doses:
2.0, 4.0, 8.0, 16.0, 32.0 and 64.0 cc/kg (64 cc/kg corresponds to a dose of 5000 mg/kg)
No. of animals per sex per dose:
5 per dose (random assignment)
Control animals:
no
Details on study design:
Animals fasted for 24 hours prior to dosing.
The animals were observed daily for a two week period for clinical signs and mortalities.
No post mortem, or histopathology examinations were performed.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths during the study period.
Clinical signs:
Unkempt coats were noted for 4-6 hours after intubation at 2.00 cc/kg.
Slight nasal haemorrhage accompanied unkempt coats at the 4.0 cc/kg dosage
At 8.0 cc/kg nasal haemorrhage and wetness around the posterior was evident. Normalcy prevailed by the third day.
Slight diarrhoea, nasal haemorrhage and wet oily unkempt coats were prevalent for 72-96 hours following dosing at 16.0 cc/kg.
The animals dosed at 32.0 cc/kg and 64.0 cc/kg exhibited lethargy, nasal haemorrhage, diarrhoea and wet, oily coats. Alopecia commenced on day 6. Weight loss was evident in these animals
Body weight:
Not measured
Gross pathology:
Not performed.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) of the test material in the rat was greater than 5000 mg/kg bodyweight.
Executive summary:

Introduction

The study was performed to assess the acute oral toxicity of the test material following oral administration in the rat. The method was performed in accordance with the US Federal Hazardous Substances Labelling Act prior to GLP.

Method

A group of 30 albino male and female rats, fasted for 24-hours were assigned one of the following dose levels at random;.2.0, 4.0, 8.0, 16.0, 32.0 and 64.0 cc/kg (64 cc/kg corresponds to a dose of 5000 mg/kg) The product was placed in a glass syringe and introduced into the stomach through the oesophagus using a stainless steel catheter. Animals on the same dose were placed in a common cage with free access to food and water. The animals were observed daily for a two week period. No post mortem, or histopathology examinations were performed.

Results

There were no deaths. Signs of toxicity noted during the study for all dose levels were unkempt coat and nasal haemorrhage. The animals dosed at 32.0 cc/kg and 64.0 cc/kg exhibited lethargy, nasal haemorrhage, diarrhoea and wet, oily coats. Alopecia commenced on day 6. Weight loss was evident in these animals.

The acute oral median lethal dose (LD50) of the test material in the rat was greater than 5000 mg/kg bodyweight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

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

The key study on the read-across substance EC 255 -485 -3 was performed in accordance with the US Federal Hazardous Substances Labelling Act prior to GLP.

A group of 30 albino male and female rats, fasted for 24-hours were assigned one of the following dose levels at random;.2.0, 4.0, 8.0, 16.0, 32.0 and 64.0 cc/kg (64 cc/kg corresponds to a dose of 5000 mg/kg) The product was placed in a glass syringe and introduced into the stomach through the oesophagus using a stainless steel catheter. Animals on the same dose were placed in a common cage with free access to food and water. The animals were observed daily for a two week period. No post mortem, or histopathology examinations were performed.

There were no deaths. Signs of toxicity noted during the study for all dose levels were unkempt coat and nasal haemorrhage. The animals dosed at 32.0 cc/kg and 64.0 cc/kg exhibited lethargy, nasal haemorrhage, diarrhoea and wet, oily coats. Alopecia commenced on day 6. Weight loss was evident in these animals.

The acute oral median lethal dose (LD50) of the test material in the rat was greater than 5000 mg/kg bodyweight.

The justification for read-across is attached in Section 13 of the IUCLID dossier.

Justification for classification or non-classification

Oral: The acute oral median lethal dose (LD50) of the test material in the rat was greater than 5000 mg/kg bodyweight. In the absence of an LD50 value below the threshold level for classification, the substance is not classified for acute toxicity.