COAGULANT 122 (SOLID)

Endpoint summary

Description of key information

Acute oral toxicity: 
The methods employed in this study were similar to those described in 40 CFR Part 798 , EPA Health Effects Testing Guidelines - Subpart B - General Toxicity Testing, September 1985. Coagulant 122 (solid) when administered as supplied to 5 male and 5 female
albino rats, appears to have an acute oral LD50 greater than 5.0 g/kg.
Acute toxicity: inhalation
No data available due exposure by inhalation being unlikely.  Two reliable studies are available (oral and dermal)
Acute dermal toxicity:
A study was performed to assess the acute dermal toxiciry of Coagulant 122 (solid) to the rat. The method followed was that described in EEC Methods for the determination of toxiciry, Annex to Directive 92/69/EEC (OJ No. L3834, 29.12.92), Part B, Method 8.3. A   The acute lethal dermal dose to rats of Coagulant 122 (solid) was found to be greater than 2.0 g/kg bodyweight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 500 mg/kg bw

Quality of whole database:

Klimish: 1

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

n/a

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Klimish: 1

Additional information

Acute Oral Toxicity:

OBSERVATIONS

Males: All animals appeared normal throughout the 14 -day observation period.

Females: All animals appeared normal throughout the 14day observation period.

GROSS PATHOLOGY

Males: no gross abnormalities were observed for the animals necropsied at the conclusion of the 14 -day observation period.

Females: no gross abnormalities were observed for the animals necropsied at the conclusion of the 14 -day observasion period.

Acute Dermal Toxicity:

MORTALITY

There were no deaths following a single dermal application of Coagulant 122 (solid) to a group of ten rats (five males and five females) as a dosage of 2.0 g/kg bodywlight.

CLINICAL SIGNS

There were no signs of systemic reaction to treatment.

DERMAL RESPONSES

Sites of application of Coagulant 122 (solid) showed no irritation or other dermal changes (scores of zero for erythema and oedema were record 1 for all animals).

BODYWEIGHT

Slightly low bodyweight gains were recorded for three males and four females on Day 8, with a similar trend noted for three males and one female on Day 15. All other rats achieved a satisfactory bodyweight gain throughout the study.

MACROSCOPIC EXAMINATION

No macroscopic abnormalities were observed for animals killed on Day 15.

Justification for selection of acute toxicity – oral endpoint
Two reliable studies available

Justification for selection of acute toxicity – inhalation endpoint
Exposure by inhalation being unlikely.
Two reliable studies available for acute oral and dermal toxicity.

Justification for selection of acute toxicity – dermal endpoint
Two reliable studies available

Justification for classification or non-classification

Acute Toxicity (Oral):

The substance tested was a ~50% solution of Coagulant 122 (solid). The LD50 value for this 50% solution was >5000
mg/kg which theoretically represents a >2500 mg/kg value for the Coagulant 122 (solid).

Acute Toxicity (Dermal):

The acute lethal dermal dose to rats of Coagulant 122 (solid) was found to be >2000 mg/kg bodyweight

Acute Toxicity (Inhalation):

Exposure by inhalation being unlikely

Based on test results: Coagulant 122 (solid) will not require labelling with H302 cat. 4: Harmful if swallowed; H312 category 4:Harmful in contact with skin", in accordance with Regulation (EC) No 1272/2008.