Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
16. Dec. - 23. Dec 1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scientific principles. (Observation period up to 7 days. Desquamation seen at day 7 in 2 animals, no data on test substance purity.)

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(Observation period up to 7 days. Desquamation seen at day 7 in 2 animals, no data on test substance purity.)
Qualifier:
equivalent or similar to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(Observation period up to 7 days. Desquamation seen at day 7 in 2 animals, no data on test substance purity.)
GLP compliance:
yes (incl. certificate)
Remarks:
Safepharm Laboratories Limited, Derby, UK

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: straw colored liquid- Analytical purity: not given, responsibility of the sponsor- Storage condition of test material: room temperature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS- Source: David Percival Ltd., Moston, Sandbach, Chesire, UK- Age at study initiation: 12 - 16 weeks- Weight at study initiation: 2.74 - 3.07 kg- Housing: individual housing in suspended metal cages - Diet: STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK, ad libitum - Water: ad libitum- Acclimation period: at least 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 17 - 20- Humidity (%): 50 - 60- Air changes (per hr): 15- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: not required: untreated site of the same animal served as control
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 mL- Concentration (if solution): undiluted
Duration of treatment / exposure:
4 hours
Observation period:
7 daysreading time points: 1, 24, 48 and 72 hours and 7 days
Number of animals:
3 (2 males and 1 female)
Details on study design:
TEST SITE- Area of exposure: 2.5 x 2.5cm on the back of each rabbit- Type of wrap if used: cotton gauze patch secured with a strip of surical adhesive tape and wrapped with an elasticated corsetREMOVAL OF TEST SUBSTANCE- Washing (if done): residual test material was removed by gentle swabbing with cotton wool soaked in 74% Industrial Methylated Spirits- Time after start of exposure: 4 hoursSCORING SYSTEM: Draize Scoring System

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: loss of skin elasticity at 72 hours and desquamation after 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: desquamation after 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
Very slight erythema was noted at all treated skin sites at the 24 and 48-hour observations and at two treated skin sites at the 72-hour observation. Very slight edema was noted at all treated skin sites at the 24-hour observation and persisted at two treated skin site at the 48 and 72-hour observations.
Other effects:
Loss of skin elasticity was noted at one treated skin site at the 72-hour observation. Slight desquamation was noted at two treated skin sites at the 7-day observation.

Any other information on results incl. tables

Table 1. Results of skin irritation study.                  
Observation time

Rabbit no.

1 2 3
Erythema Edema Erythema Edema Erythema Edema
1 h 0 0 0 0 0 0
24 h 1 1 1 1 1 1
48 h 1 0 1 1 1 1
72 h 0 0 1 1 1 1
7 days 0 0 0 0 0 0
Mean value 24 + 48 + 72 h 0,67 0,33 1,00 1,00 1,00 1,00
Mean value 24 + 48 + 72 h all animals 0,89 0,78        

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
DSD: not classifiedCLP: not classified