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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data is from authoritative database.

Data source

Reference
Reference Type:
other: Authoritative database
Title:
Dermal irritation study of test substance
Author:
U. S. National Library of Medicine
Year:
2018
Bibliographic source:
HSDB (Hazardous Substances Data Bank); US national Library of Medicine reviewed by SRC, 2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
equivalent or similar to guideline
Guideline:
other: the 49 CFR Part 173.240 method from the US Hazardous Materials Regulations
Principles of method if other than guideline:
The potential of test chemical to induce skin irritation or corrosion was assessed in adult New Zealand white rabbits (3 males and 3 females) using the 49 CFR Part 173.240 method from the US Hazardous Materials Regulations.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium phosphinate
EC Number:
231-669-9
EC Name:
Sodium phosphinate
Cas Number:
7681-53-0
Molecular formula:
H3O2P.Na
IUPAC Name:
Sodium hypophosphite
Test material form:
solid
Details on test material:
- Name of test material: sodium phosphinate
- IUPAC name: Sodium hypophosphite
- Molecular formula: NaO2P
- Molecular weight: 87.9778 g/mole
- Smiles notation: [Na+].[O-]P=O
- InChl: 1S/Na.H3O2P/c;1-3-2/h;3H2,(H,1,2)/q+1;/p-1
- Substance type: Inorganic
- Physical state: Solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
- Age at study initiation: adult

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Remarks:
(intact or abraded sites)
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 hours

Observation period:
24, 48 and 72 hours
Number of animals:
6 (3 males and 3 females)
Details on study design:
- Area of exposure: shaved backs
SCORING SYSTEM: According to the criteria laid down in EC regulation 1272/2008/EC

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Remarks:
Erythema and edema
Basis:
mean
Time point:
24/48/72 h
Score:
1
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
A slight erythema (scoring value 1) was observed in all animals at the 24-hour reading and was still persistent in 1 out of 3 animals treated onto an intact skin and 2 out of 3 animals treated on an abraded area at the 72-hour reading. Only one animal with intact skin showed a slight oedema (soring value 1) at the 72-hour reading.
Other effects:
No data

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Conclusions:
Based on the observation and according to the criteria laid down in CLP (Reg 1272/2008/EC), the test chemical was considered as non-irritant to the skin of adult New Zealand white rabbits.
Executive summary:

The dermal irritation test was conducted to determine the skin irritation potential of the given test chemical in adult New Zealand white rabbits (3 males and 3 females) using the 49 CFR Part 173.240 method from the US Hazardous Materials Regulations. the test method used was comparable to the OECD 404 guideline issued in 1981. During the study, the rabbits were dermally exposed to 500 mg of test chemical for 4 hours on prepared shaved backs. 3 animals received the test chemical onto an intact skin while the remaining received the test chemical onto an abraded area. The test substance was held in contact with the skin by means of an occlusive dressing. Cutaneous reactions were observed 24, 48 and 72 hours after removal of the dressing. The test substance caused slight erythema (scoring value 1) in all animals at the 24-hour reading and was still persistent in 1 out 3 animals treated onto an intact skin and 2 out 3 animals treated on an abraded area at the 72-hour reading. Only one animal with intact skin showed a slight oedema (soring value 1) at the 72-hour reading. Thus, according to the criteria laid down in EC regulation 1272/2008/EC and based on the observations, the test chemical was considered as non-irritant to the skin.