Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and appropriate conditions
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
Principles of method if other than guideline:
not relevant
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Aluminum Ammonium Superphosphate (Batch No. 38771-55-3), a white powder stored at room temp in a dark, dry, closed container.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
The rats were supplied by Harlan Laboratories UK Limited. On receipt the animals were randomly allocated to cages.
Acclimatisation period: At least 5 days. Animals were selected randomly and given a number unique within the study by indelible ink-marking on the tail and identified by a number written on a cage card.
Age at the beginning of the study: 8-12 weeks. Bodyweights: +- 20% of the mean weight of any previously dosed animals.
With the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing, free access to mains drinking water and food (2014 Teklad Global Rodent diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK) was allowed throughout the study.
Temperature and relative humidity: 19-25°C and 30-70% respectively.
Rate of air exchange: At least 15 changes per hours.
Lighting: 12h continuous light & 12h darkness.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Duration of exposure:
24 hours
Doses:
2000 mg/kg bodyweights
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
The appropriate amount of test material, moistened with distilled water, was applied as evenly as possible to an area of shorn skin (approximately 10 of the total body surface area). A piece of surgical gauze was placed over the treatment area and semi occluded with a piece of self-adhesive bandage. The animals were caged individually for the 24-h exposure period. Shortly after dosing the dressings were examined to ensure that they were securely in place.
After the 24-hours contact period the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove any residual test material. The animals were returned to group housing for the remainder of the study period.

Animals were observed for deaths or overt signs of toxicity 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days.
After removal of the dressings and subsequently once daily for 14 days, the test sites were examined for evidence of primary irritation and scored according to the scale from Draize J H (1977) "Dermal and Eye Toxicity Tests". Any skin reactions, if present were also recorded.
Individual bodyweights were recorded prior to application.

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: There were no deaths
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: There were no deaths
Mortality:
There were no deaths
Clinical signs:
There were no signs of systemic toxicity
Body weight:
Animals showed expected gains in bodyweight over the study period, except for one female which showed no gain in bodyweight during the first week but expected gain in bodyweight during the second week.
Gross pathology:
No abnormalities were noted at necropsy

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal median dose of the test material in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.
Executive summary:

The study was performed to assess the acute dermal toxicity of the test material following a semi occluded dermal application of the test material to intact skin of the Wistar strain rat. 5 males and 5 females were dosed at 2000 mg/kg bw. No deaths occurred and no abnormalities were noted. LD50 was found to be greater than 2000 mg/kg bodyweight.