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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 15 May 1997 and 27 May 1997.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Not applicable.
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Octylphosphonic acid
EC Number:
225-218-5
EC Name:
Octylphosphonic acid
Cas Number:
4724-48-5
Molecular formula:
C8H19O3P
IUPAC Name:
octylphosphonic acid
Test material form:
other: White solid
Details on test material:
- Name in study report: Octylphosphonic acid
- Storage condition of test material: ambient temperature (<25°C), stored under artificial light over silica gel.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.85-2.91 kg
- Fasting period before study: none
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-20
- Humidity (%): 52-66
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12:12

IN-LIFE DATES: from 15 May 1997 to 27 May 1997

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): no data
Duration of treatment / exposure:
3 minutes (3 rabbits), 1 hour and 2 hours (1 rabbit)
Observation period:
12 days
Number of animals:
3
Details on study design:
TEST SITE (3 different sites used)
- Area of exposure: 6.25 cm2
- % coverage: no data
- Type of wrap if used: elasticated corset (TUBIGRIP)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was removed at the end of each exposure period by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 3 minutes, 1 hour and 2 hours after application.

SCORING SYSTEM:
Dermal reactions were scored according to the scale of Draize (1977).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 hours
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 12 days
Remarks on result:
other: following 2 hour exposure period
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 hour
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 12 days
Remarks on result:
other: following 1 hour exposure period
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 hours
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 12 days
Remarks on result:
other: following 2 hour exposure period
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1 hour
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 12 days
Remarks on result:
other: following 1 hour exposure period
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: following 3 minute exposure period
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: following 3 minute exposure period
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: following 3 minute exposure period
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: following 3 minute exposure period
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 hours
Score:
0.5
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: following 3 minute exposure period
Irritant / corrosive response data:
Semi-occluded applications of the test material to the intact skin of one rabbit for exposure periods of 1 hour and 2 hours produced reactions indicative of dermal corrosion. The reactions included green-coloured dermal necrosis, hardened dark brown/black-coloured scab and scar tissue. A single 3-minute semi-occluded application of the test material to the intact skin of 3 rabbits produced no corrosive effects.
Other effects:
None

Any other information on results incl. tables

No other information

Applicant's summary and conclusion

Interpretation of results:
other: Classified as corrosive to skin as per the CLP Regulation EC No 1272/2008
Conclusions:
Under the test conditions of this study, OPA is classified as Skin corrosion/irritation Cat 1B: H314 (Causes severe skin burns and eye damage) according to the criteria of EC Regulation 1272/2008.
Executive summary:

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit according to OECD 404 and in compliance with GLP.

Semi-occluded applications of the test material to the intact skin of one rabbit for exposure periods of 1 hour and 2 hours produced reactions indicative of dermal corrosion. The reactions included green-coloured dermal necrosis, hardened dark brown/black-coloured scab and scar tissue.

A single 3-minute semi-occluded application of the test material to the intact skin of 3 rabbits produced no corrosive effects. The mean individual scores calculated within 3 scoring times (24, 48 and 72 hours) were 0.0, 0.0, 0.0 and 1, 0.3, 0 for edema and erythema respectively after a 3 minute exposure period.

In conclusion, under the test conditions, the test item is classified as skin corrosion/irritation Cat 1B: H314 (Causes severe skin burns and eye damage) when applied topically to rabbits according to the criteria of the Regulation (EC) 1272/2008 and as skin corrosive (C-R34) according to the criteria of the Annex VI of the Directive 67/548/EEC.

This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.