COAGULANT 122 (SOLID)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25.01.1995 - 08.02.1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

Name of test material (as cited in study report): Coagulant 122 (solid)
Substance type: Clear slightly yellow liquid
Physical state: 80.4% solids
Batch number: 9435262-8489-A
Storage condition of test material: 4°C in the dark

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Duration of exposure:

24 h

Doses:

2.0 g/kg bodyweight

No. of animals per sex per dose:

A group of ten rats (five males and five females) was treared at 2.0 g/kg bodyweight.

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: There were no signs of systemic reaction to treatment. 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 Da

Gross pathology:

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

Other findings:

Signs of toxicity (local):
There were no signs of irritation or other dermal changes.

Any other information on results incl. tables

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) at a dosage of 2.0 g/kg bodyweight.

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 recorded for all animals).

Bodyweight (tables 1 and 2)

Slightly low bodyweight gains were recorded for three males and four females on Day g, 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.

Table 1 (Individual bodyweights (g))

Sex	Dose (g/kg)	Animal number & ear mark	Bodyweight (g) at
			Day 1	Day 8	Day 15
Male	2.0	1 RP	238	279	312
		2 LP	247	299	359
		3 RPLP	251	279	314
		4 RIRO	249	281	318
		5 LILO	248	291	344
Female	2.0	6 RP	232	243	266
		7 LP	214	222	236
		8 RPLP	217	218	232
		9 RIRO	231	250	285
		10 LILO	228	234	247

Table 2 (Individual bodyweight changes (g))

Sex	Dose (g/kg)	Animal number & ear mark	Bodyweight gains (g) at
			Week 1	Week 2
Male	2.0	1 RP	41	32
		2 LP	52	60
		3 RPLP	28	35
		4 RIRO	32	37
		5 LILO	43	53
Female	2.0	6 PR	11	23
		7 LP	8	14
		8 RPLP	1	14
		9 RIRO	19	35
		10 LILO	6	13

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance tested was Coagulant 122 (solid). The LD50 value was >2000 mg/kg.
Coagulant 122 (solid) will not require labelling with H312 category 4:Harmful in contact with skin", in accordance with Regulation (EC) No 1272/2008.

Executive summary:

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. Acute toxicity (dermal).

A group of ten rats (five males and five females) was given a single dermal application of the test substance, as supplied at a dosage of 2.0 g/kg bodyweight. All animals were killed and examined macroscopically on Day 15, the end of the observation period.

There were no deaths and no signs of systemic reaction to treatment.

Sites of application of Coagulant 122 (solid) showed no irritation or other dermal changes.

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.

No abnormalities were recorded at the macroscopic examination on Day 15.

The acute lethal dermal dose to rats of Coagulant 122 (solid) was found to be greater than 2.0 g/kg bodyweight.