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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
Study period:
23 - 30 November 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

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)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Product name: Amgard V6
Appearance: very pale straw coloured viscous liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, UK
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.19 - 2.54 kg
- Housing: individually, suspended metal cages
- Diet: ad libitum (STANRAB SQC Rabbit Diet)
- Water: ad libitum
- Acclimation period:minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 20
- Humidity (%): 49 - 56
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL test material, under a 2.5 x 2.5 cm gauze patch
Duration of treatment / exposure:
4 hours
Observation period:
1 hour, 24, 48 and 72 hours after removal of patches
Additional observation at Day 7 to assess reversibility
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap: adhesive tape (BLENDERM) plus elasticated corset (TUBIGRIP)

REMOVAL OF TEST SUBSTANCE
- Washing: cotton wool soaked in diethylether
- Time after start of exposure: 4 hours

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
1.2
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: Desquamation observed after 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: desquamation observed after 7 d
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
- 1 hour: very slight erythema was noted at two treated skin sites and well-defined erythema at on skin site
- 24, 48 hours: very slight erythema persisted at all treated skin sites
- 72 hours: very slight erythema at one site, the other two skin sites appeared normal
- 7 days: desquamation at two treated skin sites, the other appeared normal

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Whilst there is some transient irritation according to Draize criteria, it is not sufficient to classify as irritant according to the EU criteria. The Classification is 'not irritating'.
Executive summary:

In a primary dermal irritation study, conducted according to OECD Guideline No.404, the shaved skin of 3 New Zealand white rabbits (females) was exposed to 0.5 ml of undiluted 2,2-bis(chloromethyl)trimethylene bis(bis(2-chloroethyl)phosphate) for 4 hours under semiocclusive conditions. The animals then were observed for up to 7 days. Irritation was scored by the method of Draize. In this study the substance was slightly irritant to rabbit skin, but the level of irritation was not suifficient for a classification as skin irritant according to EU criteria.