Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Guideline study with acceptable restrictions (only raw data were reported, information on substance identity and composition is lacking and no batch no. is given. Guideline 402 is followed with deviations. Substance identity and composition is reliability with restrictions. No Statement from company owner is received on substance identity and composition mentioned in study report)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
only raw data were reported; very limited reported study; only 2 males and 2 females tested.
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Aluminium sulphate
EC Number:
233-135-0
EC Name:
Aluminium sulphate
Cas Number:
10043-01-3
Molecular formula:
Al.3/2H2O4S
IUPAC Name:
Aluminium sulphate
Constituent 2
Reference substance name:
aluminum sulphate, hydrate
IUPAC Name:
aluminum sulphate, hydrate
Details on test material:
- Name of test material (as cited in study report): aluminum sulfate, hydrate
- Physical state: granular, no further info
- Analytical purity: not reported

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Duration of exposure:
24 h
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
2 males and 2 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: daily; weighing: at start and end of the test
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred following treatment and during the observation period at the 5000 mg/kgbw dose level.
Clinical signs:
Clinical observation data at the 5000 mg/kg bw dose:
- Males: mild/moderate erythema. Both appear normal 2 days after treatment.
- Females: moderate and severe erythema, small areas of haemorrhaging in places where large chunks of compound were pressed into the skin. Both appear normal 2 days after treatment.
Gross pathology:
Animals autopsied in the 5000 mg/kg group showed no gross abnormalities, with the exception of 1 male animal which had pale lungs.
Other findings:
No further data

Any other information on results incl. tables

Date

Sex

Dose

(mg/kg)

# deaths

Total #

animals

Clinical observations

Necropsy observations

15July1976

M

5000

0

2

After unwrapping:

- Mild/moderate erythema

Day 2:

- Appear normal

One animal with pale lungs, other animal showed no gross abnormalities

 

 

 

 

 

 

 

15July1976

F

5000

0

2

Day 1:

- Moderate and severe erythema

- Small areas of haemorrhaging in places where large chunks of compound were pressed into the skin

Day 2:

- Appear normal

No gross abnormalities

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
Executive summary:

Aluminum Sulfate, Hydrate was evaluated for its acute dermal toxicity potential in New Zealand White rabbits. The study is equivalent to the OECD Guideline 402 (Acute Dermal Toxicity) with deviations. The study wasn’t designed and performed according to Good Laboratory Practice Standards.

For 24 hours 5000 mg/kg bw test substance is applied to the skin of 2 male and 2 female rabbits. This application produced some skin irritation such as erythema and haemorrhaging after treatment. No mortality occurred. All rabbits exhibited normal appearance and behaviour on day 2. The gross necropsy showed no significant gross changes, with the exception of 1 male animal which had pale lungs..

The Single Dose Acute Dermal LD50of Aluminum Sulfate, Hydrate applied to the skin for 24 hours, is greater than 5000 mg/kg bw. Therfore the test material was not classified according to OECD-GHS.