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Administrative data

Endpoint:
acute toxicity: dermal
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 402 (Acute Dermal Toxicity)
Version / remarks:
Method described in 16 CFR Part1500.3 (c) and 1500.40, Consumer Product Safety Commission, Federal Hazardous Substances Act Regulations.
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:
yes

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:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Morton Commercial Rabbits, Parsonage Farm, Stansted, Essex
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
- Age at study initiation: 3-4 months
- Weight at study initiation: 2.04 - 2.83 kg
- Housing: individually
- Diet:. ad libitum
- Water: ad libitum
- Acclimation period: at least 2 wk

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16+/-2
- Humidity (%): 50-70
- Air changes (per hr): 17
- Photoperiod (hrs dark / hrs light): 10/14

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: physiologica l saline
Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 3times on first day, and twice daily after day 2
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

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:
No deaths occurred

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
The acute dermal toxicity of H 48 bleach was >2000 mg/kg bw. in the combined sex.
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 dermal toxicity of H 48 bleach was investigated in groups of 5 male and female New Zealand White rabbits after a single dermal administration of 2000 mg/kg bw.

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