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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:
key study
Study period:
1976
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:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1955).
Principles of method if other than guideline:
Two test sites lateral to the mid line of the back were used on each rabbit. Immediately before the application of the test compound, the right hand site was abraded. Assessments of skin reactions were made after 24 hrs and 72 hrs and for any further period considered necessary up to 14 days.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl 3-[[bis(1-methylethoxy)phosphinothioyl]thio]propionate
EC Number:
275-965-6
EC Name:
Ethyl 3-[[bis(1-methylethoxy)phosphinothioyl]thio]propionate
Cas Number:
71735-74-5
Molecular formula:
C11H23O4PS2
IUPAC Name:
ethyl 3-{[bis(propan-2-yloxy)(sulfanylidene)-λ⁵-phosphanyl]sulfanyl}propanoate
Details on test material:
- Physical state: liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 12-14 weeks
- Weight at study initiation: 2.32 kg (males) and 2.57 kg (females)
- Housing: caged individually
- Diet: A commercial irradiated diet (Styles-Oxoid) ad libitum
- Water: Sterile filtered waterad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 50-70
- Photoperiod (hrs dark / hrs light): 14 / 10

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
Duration of treatment / exposure:
24 h
Observation period:
14 d
Number of animals:
6 (3 male and 3 female)
Details on study design:
TEST SITE
- Area of exposure: The backs of the rabbits, shaved over an area of at least 10% of the total body surface. Two test sites lateral to the mid line of
the back were used on each rabbit. Immediately before the application of the test compound, the right hand site was abraded with the point of a sterile hypodermic needle. The left hand sit's remained intact.
- % coverage: 2.5 cm2
- Type of wrap if used: gauze covered with aluminum foil secured with "Sleek" adhesive tape (Smith and Nephew, Hull, England). The test sites were then covered by a 6" wide "Coban" self adhesive bandage (3M Company, Wigmore Street, London)

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize et al. (1944) J. Pharmac. Exp. Ther. 82:377

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
intact skin
Time point:
72 h
Score:
1.42
Max. score:
8
Reversibility:
fully reversible within: 72 h
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
intact skin
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
intact skin
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
intact skin
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #4
Remarks:
intact skin
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #5
Remarks:
intact skin
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #6
Remarks:
intact skin
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
intact skin
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
intact skin
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
intact skin
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
intact skin
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #4
Remarks:
intact skin
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #5
Remarks:
intact skin
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #6
Remarks:
intact skin
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
intact skin
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within:
Remarks:
72 h
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
intact skin
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Remarks:
intact skin
Time point:
48 h
Remarks on result:
not measured/tested

Any other information on results incl. tables

Erythema formation

No/ Sex Intact
Abraded
total

24 h 72 h 24 h 72 h
11/male 1 0 1 0
13 1 0 1 0
15 2 0 2 0
12/female 1 0 1 0
14 2 0 2 0
16 1 0 1 0
Mean 1.33 0.00 1.33 0.00 2.67

Oedema formation

No/ Sex Intact
Abraded
total

24 h 72 h 24 h 72 h
11/male 1 0 1 0
13 1 0 2 0
15 2 0 1 0
12/female 2 0 1 0
14 2 0 2 0
16 1 0 2 0
Mean 1.50 0.00 1.50 0.00 3.00

Erythema + Oedema = 5.67

Primary Irritation Score = 1.42

Mean erythema score of 24 and 72 hour readings, mean of all animals = 0.67

Mean edema score of 24 and 72 hour readings, mean of all animals = 0.75

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Treatment with the test substance resulted in minimal erythema and edema formations, reversible within 72h. Therefore, the substance is considered to be not irritating.
Executive summary:

In a pre-GLP study performed to assess the primary irritation potential of the test substance, six New Zealand White rabbits (three males and three females) were treated dermally with the test compound. Twenty-four hours prior to treatment, the the backs of the rabbits were shaved over an area consisting of at least 10% of the total body surface. Two test sites lateral to the mid line of the back were used on each rabbit. Immediately before the application of the test compound, the right hand site was abraded with the point of a sterile hypodermic needle. The left hand sites remained intact. 0.5 ml of the test compound was applied to each test site on a 2.5 cm2 gauze patch and covered occlusively. After 24 hours the dressing was removed and the intact and abraded application sites were assessed for oedema and erythema, a further assessment was made after 72 hours and for any further period considered necessary up to 14 days. Only minimal irritation was observed, the mean values for erythema and edema after 24 and 72 hour timepoints (all animals) were 0.67 and 0.75, respecitvely. All effects were fully reversible within 72 hours.Based on this result, the test substance is considered not irritating to the skin and does not require classification.