Fyroflex SOL-DP

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and appropriate guidelines

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Principles of method if other than guideline:

n/a

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

E-AF098T, Batch No. 474-0306-17, a white powder. Stored at room temp, dry, closed container.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Source: Harlan Italy s.r.l.
Rabbit, New Zealand White Specific Pathogen Free (SPF)
Number of animals and sex - 3 female rabbits (nulliparous and non-pregnant)
Age at order - 9 to 11 weeks old.
Weight range at arrival- 1.74 to 2.01 kg.
Husbandary: Daily average animal room temperature and relative humidity: 19± 2oC and 55±15%, respectively.
Light: 12 hr artificial light 12 hr dark.
Accommodation: Individually in labelled cages
Acclimatisation period was at least 5 days before start of the treatment
Diet- STANRAB (P) SQC, Special Diets Services, Witham, Essex CM8 3AD, UK ad libitum thorought the day.
Water- Drinking water was supplied to each cage via a water bottle ad libitum.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not required

Amount / concentration applied:

0.5g

Duration of treatment / exposure:

4 h

Observation period:

Approximately 1, 24, 48 and 72 hours after the end of the 4 hour exposure period.

Number of animals:

3 animals

Details on study design:

As the irritancy of the substance was unknown, a single animal was dosed to address potential irritation of the test item. As the response to treatment was considered to be within acceptable limits, a futher 2 animals were dosed, bringing the animal's group size to 3.
On the day before dosing a suitable test site was clipped free of hair on both sides of the mid-line of the dorsal surfaces of the trunk of each animal (approximately 15 x 10 cm).
The test item was used in the form suplied (solid), however, weighed aliquots of 0.5g were mixed to a paste using 0.5 ml of sterile water, just before dosing.
A quantity of 0.5 grams of the test material was spread evenly over a 2.5cmx 2.5cm cotton gauze pad and placed onto the animal's skin with the test item in direct contact with the skin. A strip of synthetic film was placed over the treated site and the whole assembly held in place by encircling the trunk of the animal with a length of elastic adhesive bandage. 4-hours after application the patches were removed and residual test material removed.
Mortality and morbidity were observed twice daily.
Bodyweight was taken on Day 1 and on termination (Day 4).
Skin reaction was scaled approximately 1, 24, 48 and 72 hours after the end of the 4 hour exposure period.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Reversibility:

no data

Remarks on result:

other: No signs of dermal irritation were observed.Thus, no need to present data on reversibility.

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Reversibility:

no data

Remarks on result:

other: No signs of dermal irritation were observed.Thus, no need to present data on reversibility.

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Reversibility:

no data

Remarks on result:

other: No signs of dermal irritation were observed.Thus, no need to present data on reversibility.

Results 4

Irritation parameter:

erythema score

Max. score:

0

Reversibility:

no data

Remarks on result:

other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Reversibility:

no data

Remarks on result:

other: No signs of dermal irritation were observed.Thus, no need to present data on reversibility.

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Reversibility:

no data

Remarks on result:

other: No signs of dermal irritation were observed.Thus, no need to present data on reversibility.

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Reversibility:

no data

Remarks on result:

other: No signs of dermal irritation were observed.Thus, no need to present data on reversibility.

Results 8

Irritation parameter:

edema score

Max. score:

0

Reversibility:

no data

Remarks on result:

other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)

Irritant / corrosive response data:

Corrosion: There was no evidence of a corrosive effect on the skin
Colouration: No staining of the treated skin by the test substance was observed
Toxicity/Mortality: There was no indication of a systemic toxicity effect in the animals during the test period and no mortality occurred.
Changes in body weight during the course of the study were not remarkable.

Other effects:

No erythema or oedema was apparent following a 4 hour period
of exposure to the test item in any animal of the study.

There was no indication of a systemic effect. Soft
faeces and mucus were noted on litter tray of a single
animal at the 48 hour observation. These things were not
considered treatment-related. Changes in body weight during
the course of the study were not remarkable.

Any other information on results incl. tables

No further information.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information not classified Criteria used for interpretation of results: EU

Conclusions:

Based on these results and according to the EEC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC, 27th April 1993), E-AF098T (SOL-DP) does not have to be classified and has no obligatory labelling requirement for skin irritation.

Executive summary:

n/a