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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study, performed according to standard method.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrakis(hydroxymethyl)phosphonium sulphate(2:1)
EC Number:
259-709-0
EC Name:
Tetrakis(hydroxymethyl)phosphonium sulphate(2:1)
Cas Number:
55566-30-8
Molecular formula:
C4H12O4P.1/2O4S
IUPAC Name:
tetrakis(hydroxymethyl)phosphonium sulphate(2:1)
Test material form:
other: liquid stored in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Froxfield Farms, UK
- Age at study initiation: 10-13 weeks old
- Weight at study initiation: 2.3-3.0 kg
- Housing: individually housed in metal cages
- Diet / water: free access to tap water and SDS Standard Rabbit Diet.
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature: 19°C
- Humidity 30-70 %
- Air changes: 19 per hour
- Photoperiod: 12 hr dark / 12 hr artificial light

IN-LIFE DATES: From 24 to 27 january 1989

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
undiluted, 0.5 mL/rabbit (expressed as active substance) that is a dose of 0.2 mL/cm².
Duration of treatment / exposure:
4 hour(s)
Observation period:
14 days
Number of animals:
6 (4 males and 2 females)
Details on study design:
TEST SITE
- Area of exposure: Dorsal area of the trunk
- % coverage: approximately 10 cm2
- Type of wrap if used: 2.5 cm² gauze maintained in contact with the skin with elastic adhesive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: with water
- Time after start of exposure: 4h

SCORING SYSTEM: Erythema and oedema formations were both scored from 0 (no reaction) to 4 (severe reaction). Draize scores.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
Throughout the observation period of 14 days of observation, no dermal  response (erythema, oedema) was seen in any treated animal.
Other effects:
Throughout the observation period of 14 days of observation, no clinical signs was seen in any treated animal.

Any other information on results incl. tables

Table 8.1.1: Skin irritation data

Volume applied (mL)

Sex

Number of treated animals

Erythema (E) / Oedema (O)

Mean scores

Day 1*

Day 2

Day 3

Day 4

0.5

M

4

E

0

0

0

0

O

0

0

0

0

F

2

E

0

0

0

0

O

0

0

0

0

* Approximately 30 minutes after removal of the dressing

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions of this study, the active substance THPS 75% was considered as not irritating to skin and not classified according to EU criteria.
Executive summary:

In a primary dermal irritation study performed according to the US EPA Pesticide Assessment Guidelines, Subdivision F, § 81-5 in compliance with the EPA OPPTS 870.2500, OECD 404 guidelines and in compliance with GLP, six animals (4 males and 2 females) were dermally exposed to 0.5mL of THPS at 75% in water for 4 hours under a semi-occlusive dressing.

Cutaneous reactions were observed approximately 24, 48 and 72 hours after removal of the dressing and then daily until day 14. The mean values of the scores for erythema and oedema were calculated for each animal.

No dermal irritation was elicited by product application throughout the observation period in any animal. The scores for both erythema and oedema are 0 for all animals.The active substance seems not to be irritant or corrosive via skin exposure.

Under the test conditions of this study, the active substance THPS 75% was considered as not irritating to skin and not classified according to the criteria of the CLP Regulation (EC) N°1272/2008.

 

This skin irritation study is classified as acceptable. It satisfies the guideline requirement for a skin irritation in the rabbit.