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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and appropriate guidelines
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
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 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

Resultsopen allclose all
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.
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.
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.
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)
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.
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.
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.
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