Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test guideline compliant study
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Classification according to Draize system was not applicable due to severe dermal reaction.
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Classification according to Draize system was not applicable due to severe dermal reaction
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Danafloat 123 (Sodium O,O-diethyl phosphorodithioate, EP1-Na)
- Molecular formula (if other than submission substance): (CH3CH2O)2PS2Na
- Physical state: light brown liquid
- Analytical purity: 49.2% w/w
- Impurities (identity and concentrations):
- Lot/batch No.: 80929-00
- Storage condition of test material: ambient in dark
- Other: pH 12.8

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 3.03 - 3.16 kg
- Housing: suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 21°C
- Humidity (%): 44 - 70%
- Air changes (per hr): 15/hour
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 49.2% active ingredient

VEHICLE
No vehicle used; test substance was applied as supplied.
Duration of treatment / exposure:
3 minutes, 1 hour and 4 hours
Observation period:
Approximately one hour following the removal of the patches and 24, 48 and 72 hours later as well as 7 and 14 days after exposure, the test sites were examined.
Number of animals:
3; one animal was treated initially after which two additional animals were treated.
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 4 cm
- Type of wrap if used: elasticated corset

Results and discussion

In vivo

Results
Irritation parameter:
other: erythema and oedema
Basis:
animal: 1, 2 and 3
Score:
> 2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: adverse reactions prevented the accurate evaluation of erythema and oedema.
Other effects:
No other effects.

Any other information on results incl. tables

Application of the test substance for 4 hours resulted in severe erythema and oedema, green coloured necrosis, haemorrhage of the dermal capillaries, loss of skin elasticity and flexibility, light brown discolouration of the epidermis, a hardened light brown-coloured scab, a hardened dark-brown / black-coloured scab, reduced regrowth of fur, glossy skin, scar tissue and well-defined erythema surrounding other skin reactions.

A one-hour application of the test material produced well-defied erythema, very slight oedema, haemorrhage of the dermal capillaries, loss of skin elasticity and flexibility, light brown discolouration of the epidermis, crust formation and reduced regrowth of fur.

A 3-minute application resultet in well-defined erythema, very slight oedema, loss of skin elasticity and slight desquamation.

On occasions it was not possible to accurately evaluate the erythema and oedema due to the other reactions observed.

No effects on bodyweight were observed during the 14-day observation period.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The presence of scar tissue at one skin site following a 4-hour exposure period was indicative of full thickness tissue destruction. The test material Danafloat 123, containing 49.2% EP1-Na, is therefore classified as corrosive. Classification according to the Draize system was not applicable.
Executive summary:

The study was performed to assess the irritatany potential of Danafloat 123, containing 49.2% EP1-Na, to the skin of rabbits. The method used followed the recommendations of the OECD guideline 404 and Method B4 of Comission Directive 92/69/EEC.

A 4 -hour semi-occluded application of the test material to intact skin produced severe erythema and oedema besides other severe skin reactions. As well, exposure durations of one hour and 3 minutes resulted in well-defined erythema and very slight to slight oedema, loss of skin elasticity, skin discolouration, crust formation and reduced regrowth of fur. On occasions, it was not possible to accurately evaluate the reythema and oedema due to the other skin reactions observed.

The presence of scar tissue at one skin site following a 4 -hour exposure period was indicative of full thickness tissue destruction. The test material was therefore classified as corrosive. Classification according to the Draize system was not applicable.