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Description of key information

In a reliable OECD guideline study (NIER 2002) the sensitisation potential of calcium sulfate dihydrate was investigated in male guinea pigs in a Buehler test. All test groups except the positive control had a sensitisation score of 0 (no visable change) for both induction and challenge. Calcium sulfate dihydrate is therefore not considered to be a skin sensitizer.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed to GLP and guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Existing in vivo study in guinea pigs available
Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 5-6 weeks old
- Weight at study initiation: 306.4 - 457.9 g



Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
pre-treatment had conducted with 13 %, 25 %, 50 % and 100 % of test substance.
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
100 %
No. of animals per dose:
40 animals in total:
10 vehicle control
20 test substance
10 positive control
Details on study design:
A patch (Whatman # filter paper, 2 x 2 cm) including 0.4 g of test material, which was dissolved in 0.4 mL of sterile distilled water, was applied to the abraded and intact sites on the shaved backs (4 x 4 cm) of Guinea pigs. . It was held in place for 6 hours with three fold gauze patches, which were applied in place with elasticity bandage (6.4 cm width) to prevent leakage.


After 6 hours, three fold gauze patches were removed and the exposed areas washed using warm water without altering the existing response or the integrity of the epidermis. The skin of animals was examined in accordance with the sensitization grading system and scored at 1 and 24 hours after the patches removal for induction; and 24 and 48 hours after the patches removal for challenge.

The test of induction on the skin was performed 3 times on the day 0, 7 and 14 but the test of challenge was performed 2 weeks after the final test of induction.









Positive control substance(s):
yes
Remarks:
0.1% 1-Chloro-2,4-dinitrobenzene (solvent: 10% Propylene Glycol)
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.2 mL
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.2 mL
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.1 % CDNB (in 10 % PG). 0.2 mL
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.1 % CDNB (in 10 % PG). 0.2 mL
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Interpretation of results:
other: not sensitising
Conclusions:
All test groups except the positive control had a sensitization score of 0 (no visible change) for both the induction and challenge test. Calcium sulfate dihydrate is not-sensitizing.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

There are no specific animal studies to assess respiratory sensitisation but the inhalation study showed no evidence of respiratory sensitisation potential

Justification for classification or non-classification

Calcium sulfate was shown to be non-sensitising in a guideline skin sensitisation study in animals and therefore requires no classification CLP.