Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
In vivo study performed prior to the update of REACH in 2016.
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Animals were examined at 24 and 72 hours only. No data reported on reversibility of effects. Study uses intact and abraded skin. No controls were included in the study.
Qualifier:
equivalent or similar to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Animals were examined at 24 and 72 hours only. No data reported on reversibility of effects. Study uses intact and abraded skin. No controls were included in the study.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material : Disodium phosphate
- Analytical purity: No data

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
No data

Test system

Type of coverage:
not specified
Preparation of test site:
other: Shaved, abraded and intact
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied : 0.5 g


VEHICLE
Used as received.
Duration of treatment / exposure:
24 hours
Observation period:
Up to 72 hours
Number of animals:
6, 3 males and 3 females.
Details on study design:
TEST SITE
- Type of wrap if used: Rubber (occlusive)


REMOVAL OF TEST SUBSTANCE
No data


SCORING SYSTEM:
The Draize dermal method of testing primary irritant substance as described in the Code of Federal Refulations under the Federal Hazardous Substances Labelling Act, Part 191.11, Chapter 1, Title 21.

Compounds producing combined averages (primary irritation indexes) of 2 or less are only mildly irritating; indexes from 2 to 5 are moderate irritants and those with scores above 5 are considered severe or primary irritants.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hrs
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hrs
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
The primary dermal irritation index is calculated by the following:

Total ÷ 4 = Primary dermal irritation index
Other effects:
No data

Any other information on results incl. tables

Table 1: Results for Disodium phosphate

Exposure time Hours

Rabbit No.

Mean

 

8M

15M

16M

32F

33F

34F

 

Score

Score

Score

Score

Score

Score

Erythema

24

Intact

1

1

0

0

0

0

0.33

72

Intact

0

0

0

0

0

0

0.00

24

Abraded

3

4

3

3

3

4

3.33

72

Abraded

3

3

3

3

3

2

2.83

Subtotal

6.49

Oedema

24

Intact

0

0

0

0

0

0

0.00

72

Intact

0

0

0

0

0

0

0.00

24

Abraded

1

2

1

1

1

1

1.17

72

Abraded

2

1

2

1

1

1

1.33

Subtotal

2.50

Total score

8.99

(Total/4) Primary Irritation Index

2.25

Result

Moderate Irritant

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
This study has been selected as the key study because the results are sufficient in order to derive a reliable conclusion on classification and labelling when viewed in conjunction with the supporting data.
Disodium hydrogenorthophosphate is not considered to be classified according to Regulation (EC) No. 1272/2008 (EU CLP).