Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Remarks:
Study was performed prior to the update of the REACH Regulation and prior to the validation of in vitro test methods.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

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
Type:
Constituent
Details on test material:
- Name of test material : Sodium acid pyrophosphate
- 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:
animal #1
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
other: remaining 5 animals tested
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
other: all animals tested
Time point:
24/48/72 h
Score:
0
Max. score:
4
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 Sodium acid pyrophosphate

Exposure time Hours

Rabbit No.

Mean

 

8M

15M

16M

32F

33F

34F

 

Score

Score

Score

Score

Score

Score

Erythema

24

Intact

1

0

0

0

0

0

0.17

72

Intact

0

0

0

0

0

0

0.00

24

Abraded

4

4

4

2

4

2

3.33

72

Abraded

4

4

4

0

0

0

2.00

Subtotal

5.50

Oedema

24

Intact

0

0

0

0

0

0

0.00

72

Intact

0

0

0

0

0

0

0.00

24

Abraded

4

4

4

1

3

1

2.83

72

Abraded

4

4

4

0

0

0

2.00

Subtotal

4.83

Total score

10.33

(Total/4) Primary Irritation Index

2.58

Result

Mild Irritant

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Sodium acid pyrophosphate was determined to be a mild irritant to rabbit skin with a primary dermal irritation score of 2.58, mostly the reactions were noted in abraded skin.
This study is selected as the key study because the results are sufficient in order to derive a reliable conclusion on classification and labelling. The substance is not considered to be classified in accordance with Regulation (EC) No. 1272/2008 (EU CLP) as only mild effects are noted in 1 animal at the 24 hour time period and therefore due to the mild nature of the reaction and considering it was only observed in one animal for the parameter erythema the absence of 48 hr scores is not considered to have a detrimental effect on the reliability of the study for use in classification and labelling.