Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 May 1990 to 22 May 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline and GLP compliant study with no deviations
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): R0 31-9373/000
- Physical state: white powder
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Lot/batch No.: 1354, 122
- Stability under test conditions: no data
- 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:Ranch Rabbits, Crawley Down, Sussex
- Age at study initiation:10-12
- Weight at study initiation: circa 2 kg on arrival, no data for study initiation
- Housing: individually in metal grid-bottomed cages
- Diet (e.g. ad libitum): SQC standard rabbit pellets supplied by Special Diet Services, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):17-20°C
- Humidity (%):56-65%RH
- Air changes (per hr):no data
- Photoperiod (hrs dark / hrs light): 12h/12h

IN-LIFE DATES: From: 15 May 1990 To: 22 May 1990

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: de-ionised water, 0.5 mL, used to form a paste of the 0.5g of test material powder for optimising dermal contact
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g, made into a paste with 0.5 ml of de-ionised water
- Concentration (if solution): not applicable

VEHICLE
- Amount(s) applied (volume or weight with unit):0.5 ml of de-ionised water
Duration of treatment / exposure:
4 hours
Observation period:
Seven days. Dermal assessments were completed at 24, 48 and 72 hours after completion of the application and then at 7 days after dosing.
Number of animals:
Three New Zealand White rabbits
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage:Not applicable
- Type of wrap if used: surgical lint patch covered by elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done):water moistened cotton woll used to wipe away test material residue
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize, according to requirements of B.S. 950 for assessment of colour under artificial light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 hours
Score:
0
Max. score:
4
Reversibility:
other: No reactions observed
Remarks on result:
other: No erythema observed for any of the treated sites
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 hours
Score:
0
Max. score:
4
Reversibility:
other: No oedematous reactions observed
Remarks on result:
other: No oedema recorded at any of the three treated sites
Irritant / corrosive response data:
No irritation or evidence of corrosion observed at any of the three treated sites
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Ro 31-9373/000, PTH-decahydroamide, elicited no reactions typical of skin irritation in three rabbits exposed for four hours according to the extant test guidelines. The test material does not require classification for skin irritation according to either the DPD or GHS (CLP) regulations.
Executive summary:

In a guideline complaint study three rabbits were exposed to PTH decahydroamide for four hours under a semi-occlusive dressing. The treated sites were assessed for signs of dermal irritation at 24, 48 and 72 hours after dosing and again 7 days after treatment. No signs of dermal irritation were observed at any point during the study. No classification is required for skin irritation potential of

PTH decahydroamide.