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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Methods generally follow accepted procedures for acute dermal toxicity studies. The applied dose exceeds current requirements and the result is considered valid.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: FHSLA, CFR. Title 21. para. 191.10 and Appraisal of the Safety of 'Chemicals in Foods, Drugs and Cosmetics, Association of Food and Drug Officials of the U.S.
GLP compliance:
no
Test type:
other: limit test
Limit test:
yes

Test material

Constituent 1
Reference substance name:
50% calcium DNNSA (CAS 57855-77-3)
IUPAC Name:
50% calcium DNNSA (CAS 57855-77-3)
Details on test material:
A dark brown very viscous liquid

Test animals

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

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Five male and 5 female rabbits were prepared by cl ipping the skin of the trunk
free of hair. Epidermal abrasions were made over a 5-6 cm2 area on 2 males and 3
females. A patch containing 20 g/kg body weight of the test material was placed over a
5-6 cm2 area on all rabbits and secured with an elastic sleeve. The rabbits were immobil ized
in head stocks for 24 hours at which time the patches were removed and the rabbits returned
to their cages. Feed and water were provided ad libitum. The rabbits for observed for 14 days.
Duration of exposure:
24 hours
Doses:
20 g/kg bw
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 20 other: g / kg bw
Mortality:
No mortality.
Clinical signs:
other: Anorexia - first 5 days, some weight loss, reversed after 9 days.

Any other information on results incl. tables

Rabbit-No.

Sex

BodyWeight

kg

Dose

grams

Mortality

- Day -

1-abraded

M

3.0

60

Survived

2-abraded

M

3.0

60

Survived

3

M

2.92

59

Survived

4

M

2.88

57

Survived

5

M

2.92

58

Survived

6-abraded

F

2.33

47

Survived

7-abraded

F

2.46

49

Survived

8-abraded

F

2.60

52

Survived

9

F

2.75

55

Survived

10

F

2.68

54

Survived

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The dermal LD50 > 20g/kg. The dermal LD50 on an active ingredient basis is > 10 g/kg (10,000 mg/kg).
Executive summary:

A dermal acute toxicity study was conducted with NASUL 729. This formulation contains 50% Calcium DNNSA.

Five male and 5 female rabbits were prepared by cl ipping the skin of the trunk free of hair. Epidermal abrasions were made over a 5-6 cm2 area on 2 males and 3 females. A patch containing 20 g/kg body weight of the test material was placed over a 5-6 cm2 area on all rabbits and secured with an elastic sleeve. The rabbits were immobil ized in head stocks for 24 hours at which time the patches were removed and the rabbits returned to their cages. Feed and water were provided ad libitum. The rabbits for observed for 14 days.

No mortalities occurred. Anorexia was reported for the first 5 days, some weight loss occurred but reversed after 9 days. NASUL 729 is practically non-toxic by dermal exposure.