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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
4 March 1986 to 6 March 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP compliant study conducted largely in accordance with an appropriate guideline but with a deviation in the type of dressing used.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
occusive (polythene) rather than semi-occusive dressing was used. An observation was carried out immediately after patch removal rather than after 60 minutes. Neither of these deviations are considered to significantly impact on the validity of the study.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Diammonium bis[carbonato-O]dihydroxyzirconate
EC Number:
269-682-7
EC Name:
Diammonium bis[carbonato-O]dihydroxyzirconate
Cas Number:
68309-95-5
Molecular formula:
C2H2O8Zr.2H4N
IUPAC Name:
Diammonium bis[carbonato-O]dihydroxyzirconate
Details on test material:
Aqueous solution of ammonium zirconium carbonate containing 20% ZrO2.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Male albino rabbits of the New Zealand White strain (Regal Rabbits, Great Bookham, Surry) were housed individually in metal grid-floored cages in rooms maintained at 18-23°C with a relative humidity in the range of 43-74%. They had free access to a nutritionally adequate diet (Grain Harvester's special rabbit diet 679) and tap water. The rabbits were acclimatised to the environment for 14 days before treatment.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
4
Details on study design:
The rabbits were selected on the basis of being free from significant hair growth on the dorsal surface after being clipped at least 24 hours previously. The test article was applied to one area of intact skin on each rabbit. 2.5cm square patches were applied to the skin on 6cm square patches of
polythene held in place by adhesive tape (lasso tape, Smith and Nephew Tapes Ltd) and elastic net bandage (Netlast, Roussel Laboratories). The test article was applied to the patch as a 0.5 g aliquot. The patches were removed after 4 hours and excess material washed off with tap water. The skin reactions were evalauted after washing and at 24, 48 and 72 hours after patch removal. Numerical scores were awarded and indices or irritation were calculated for each animal.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 0 hours
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 0 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No skin reactions were observed in any of the animals at any of the observation points. The substance has therefore been found not to be a skin irritant under the conditions of the study.
Executive summary:

A GLP compliant study has been conducted accordingly to OECD Guideline 404. No skin reactions were observed in any of the animals at any of the observation points. The substance has therefore been found not to be a skin irritant under the conditions of the study.