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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

Constituent 1
Chemical structure
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:
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.
Body weight:
Surviving animals had expected weight gains during the 14-day observation period.
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.

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