Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

OECD 401 (1987)

Deviations:

not applicable

GLP compliance:

no

Remarks:

Study was performed under the control of a quality assurance unit similar to GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-)

EC Number:

279-013-0

EC Name:

Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-)

Cas Number:

78948-87-5

Molecular formula:

C16H8MgO10.2H

IUPAC Name:

Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-)

Details on test material:

Test material: Magnesium-monoperoxyphthalate-hexahydrate, H48 Bleach
- Source and lot/batch No.of test material: 0525
- Further relevant properties: White powder with a faint pungent odour

Test animals

Species:

rat

Strain:

CD-1

Sex:

male/female

Details on test animals or test system and environmental conditions:

Source Charles River (U.K). Limited, Margate, Kent
Age/weight at study initiation 108-152 g (males); 100-155 g (females), both about 6 weeks old
Acclimation period: 6 wk
Fasting period before study: 18 h


Temperature 22 ± 2°C
Relative humidity 50 - 70% R.H.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Concentration in vehicle: No data
Total volume applied: H 48 bleach: Not exceeding 80 mL/kg bw; Detergent base: 20 mL/kg bw; 10 % H 48 bleach in detergent base: 20 mL/kg bw

Doses:

Dose/Concentration: H 48 bleach: 1200, 1427, 1697, 2018, 2400, or 2854 mg /kg bw; Detergent base: 5000 mg /kg bw; 10 % H 48 bleach in detergent base: 5000 mg /kg bw

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

Clinical examinations: three times (during the first hour p.a. and twice daily thereafter. Body weights on days 1, 8 and at termination. Necropsy from all pre-terminal deaths and all survivors at termination.

Statistics:

Method of determination of LD50: Probit analysis; Finney (1952), pp 236-245; Cambridge University Press or moving average interpolation according to Thompson (1947), Bact. Rev.11, 115 and Biometrics 8, 51 (in case the Probit analysis failed to demonstrate a linear dosage/mortality response)

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 262 mg/kg bw

Based on:

test mat.

Mortality:

Death occurred after dosages of 1427 mg/kg and above (for further details see Table 1-1).

Clinical signs:

other: Principal signs at all dosages were decreased motor activity and hunched posture. Less frequent signs were proneness, ataxia, muscle spasticity, piloerection and signs of respiratory distress.

Gross pathology:

External: Muzzle stained; perianal staining;
Internal: Abnormal gastro-intestinal contents (fluid, mucus, creamy material) and congestion of the pyloric wall.
Occasional findings were: Cases of brain congestion, mottled appearance of the liver, incomplete collapse and pale-green areas on all lung lobes.

Any other information on results incl. tables

LD50 2201 mg/kg in males and 2357 mg/kg in females

Dose	Number of dead / number of investigated		Time of death (range)	Observations
H 48 bleach	M(ales)	F(emales)
1200 mg/kg	0/5	0/5	-	Day 1, F: Decreased motor activity (5/5), hunched (2/5)
1427 mg/kg	0/5	1/5	Day 1, 4h after dosing	Day 1, M: Decreased motor activity (5/5), hunched (5/5) Day 1, F: Decreased motor activity (5/5), hunched (5/5)
1697 mg/kg	0/5	0/5		Day 1, M: Decreased motor activity (5/5), hunched (5/5) Day 1, F: Decreased motor activity (5/5), hunched (5/5)
2018 mg/kg	3/5	2/5	Day 1, 2-4 h after dosing	Day 1, M: Decreased motor activity (5/5), hunched (5/5) ataxia (4/5), muscular spastic (3/5), prone (3/5) Day 1, F: Decreased motor activity (5/5), hunched (5/5) ataxia (3/5) prone (3/5)
2400 mg/kg	2/5	2/5	Day 1, 4 h after dosing – Day 2, a.m.	Day 1, M: Decreased motor activity (5/5), hunched (5/5) ataxia (2/5), muscular tremor (2/5) Day 1, F: Decreased motor activity (5/5), hunched (5/5) ataxia (2/5) prone (2/5), muscular tremor (2/5)
2854 mg/kg	5/5	4/5	Day 1, 1 h after dosing – Day 2, a.m	Day 1, M: Lethargic (2/5), decreased motor activity (5/5), hunched (5/5), bradypnoea (3/5), hyperpnoea (5/5), piloerection (5/5) Day 1, F: Lethargic (2/5), decreased motor activity (5/5), prone (1/5), hunched (5/5), ataxia (3/5), bradypnoea (3/5), hyperpnoea (5/5), gasping (1/5), piloerection (2/5)
LD50value	Males: 2201 mg/kg; Females: 2357 mg/kg; Combined sexes: 2262 mg/kg (Probit analysis) (Thompson’s moving average interpolation for males))

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The acute oral toxicity of H 48 bleach was 2262 mg/kg bw. in the combined sex (2201 mg/kg in males, 2357 mg/kg in females).
According to Directive 67/548/EEC and CLP GHS, H 48 bleach requires no classification, as the acute oral LD50 was >2000 mg/kg of body weight.

Executive summary:

The acute oral toxicity of H 48 bleach was investigated in groups of 5 fasted male and female Charles River CD rats after a single oral administration. Dosages for H 48 bleach ranged from 1200 to 2854 mg/kg bw. Animals treated with H 48 displayed signs of reaction to treatment at all dose levels (principal signs: decreased motor activity and hunching). Deaths occurred at doses of 1427 mg/kg and above on Day 1 or during the first overnight period. Necropsy of decedents of animals dosed with H 48 bleach revealed externally muzzle and, occasionally perianal staining. Internal findings included abnormal gastro-intestinal contents, pallor of the pyloric walls and, occasionally, brain congestion and mottled appearance of the liver.