Reaction mass of copper and iron and zinc

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From July 5 1994 to July 19 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Olac Ltd., Bicester, Oxon, England
- Age at study initiation: four to seven weeks of age
- Weight at study initiation: 94-113 g
- Housing: in groups of up to five rats of the same sex in metal cages
- Diet: ad libitum, but it was prevented overnight prior to and approximately 4 hours after dosing
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-25
- Humidity (%): 68
- Air changes (per hour): 10-15
- Photoperiod (hours dark / light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: aqueous methylcellulose

Details on oral exposure:

The test material was prepared at a concentration of 20% w/v in 1% w/v aqueous methylcellulose and administered at a volume of 10 ml/kg bodyweight.

The test substance was prepared on the day of dosing.

Doses:

2.0 g/kg bodyweight

No. of animals per sex per dose:

A group of ten rats (five males and five females)

Control animals:

no

Details on study design:

OBSERVATIONS
Mortality
Cages of rats were checked a least twice daily for any mortalities.

Clinical signs
Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1 (a period of fine hours). On subsequent days (with the exception of Day 15 – morning only) animals were observed once in the morning and again at the end of the experimental day. This latter observation was at approximately 16:30 hours on week days or 11:30 hours on Saturdays and Sundays. The nature and severity of the clinical signs and time were recorded at each observation. All animals were observed for 14 days after dosing.

Bodyweight
The bodyweight of each rat was recorded on Days 1 (prior to dosing), 8 and 15. Individual weekly bodyweight changes were calculated.

TERMINAL STUDIES
Termination
All were killed on Day 15 by cervical dislocation.

Macroscopic pathology
All animals were subjected to a macroscopic examination which consisted of opening the abdominal and thoracic cavities. The macroscopic appearance of all tissues was recorded.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths following a single oral dose of the test substance at 2.0 g/kg bodyweight.

Clinical signs:

Piloerection was observed in all rats within five minutes of dosing. This sign persisted throughout Day 1 and much of Day 2. There were no other clinical sign and recovery, as judged by external appearance and behavior, was complete by the second observation on Day 2.

Body weight:

All rats achieved anticipated bodyweight gains throughout the study.

Gross pathology:

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

Any other information on results incl. tables

Individual bodyweights (g) of rats dosed orally

			Bodyweight (g) at
Sex	Dose (g/kg)	Animal number & ear mark	Day 1	Day 8	Day 15
Male	2	1 RP	113	195	265
		2 LP	100	179	237
		3 RPLP	101	167	221
		4 RIRO	95	170	222
		5 LILO	94	166	221
Female	2	6 RP	107	152	179
		7 LP	109	160	193
		8 RPLP	98	147	179
		9 RIRO	103	147	182
		10 LILO	102	150	182

Individual bodyweight changes (g) of rats dosed orally with the test substance

			Bodyweight (g) at
Sex	Dose (g/kg)	Animal number & ear mark	Week 1	Week 2
Male	2	1 RP	82	70
		2 LP	79	58
		3 RPLP	66	54
		4 RIRO	75	52
		5 LILO	72	55
Female	2	6 RP	45	27
		7 LP	51	33
		8 RPLP	49	32
		9 RIRO	44	35
		10 LILO	48	32

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute lethal oral dose to rats of the test substance was found to be greater than 2.0 g/kg bodyweight..

Executive summary:

A study was performed to assess the acute oral toxicity of the test substance to the rat. The method followed was that described in the OECD Guideline for Testing of Chemicals No. 401.

 

A group of ten fasted rats (five males and five females) was given a single dose by oral gavage of the test substance, formulated in 1% w/v aqueous methylcellulose, at a dose level 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. Clinical signs of reaction to treatment were confined to piloerection, recovery was complete by the second observation on day 2. All rats achieved satisfactory bodyweight gains throughout the study. No abnormalities were recorded at the macroscopic examination on Day 15. The acute lethal oral dose to rats of the test substance was found to be greater than 2.0 g/kg bodyweight.