Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 october 1989 to 14 october 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study following OECD and EU guidelines, with minor deviations: no certificate of analysis and housing temperature
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:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
No certificate of analysis, deviation in housing temperature
Principles of method if other than guideline:
Not applicable
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): ER 195
- Physical state: white crystalline powder
- Lot/batch No.: DG6
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, U.K.
- Age at study initiation: approximately 12 weeks to 16 weeks old
- Weight at study initiation: 2.12 - 2.30 kg
- Housing: individually housed in suspended metal cages
- Diet (e.g. ad libitum): rabbit diet (Preston Farmers limited, New Leake, U.K.), ad libitum
- Water (e.g. ad libitum): normal drinking water, ad libitum
- Acclimation period: after a minimum acclimatisation period of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-20
- Humidity (%): 62-65
- Air changes (per hr): approximately 15 changes/h
- Photoperiod (hrs dark / hrs light): 12 h light and 12 h dark

IN-LIFE DATES: From: 11 October 1989 To 14 October 1989

Test system

Type of coverage:
other: elasticated corset
Preparation of test site:
other: clipped dorsal and flank area
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with 0.5 mL of distilled water

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: 2.5 cm x 2.5 cm gauze patch secured with a strip of surgical adhesive tape. The trunk was wrapped in an elasticated corset (Tubigrip)

REMOVAL OF TEST SUBSTANCE
- Gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize J. H. scale (1959)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal #1
Remarks:
mean individual score
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
overall irritation score
Basis:
animal #2
Remarks:
mean individual score
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
overall irritation score
Basis:
animal #3
Remarks:
mean individual score
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
No irritation
Other effects:
No data

Any other information on results incl. tables

No data

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was regarded as not irritating according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation (EC) N° (1272-2008).
Executive summary:

In a primary dermal irritation GLP study performed according to OECD guideline 404, three young adult male White New-Zealand rabbits were dermally exposed to 0.5 g of ER 195 in 0.5 mL of distilled water for 4 hours to 6.25 cm² of clipped skin. Animals then were observed for 3 days. Irritation was scored by the method of Draize (1959).

There was no irritant effect at any observation time point. In this study, ER 195 is not a dermal irritant on male rabbits.

Under the test conditions, ER 195 is not classified as irritating to the skin according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation (EC) N° (1272-2008).