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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Lithium phosphorodifluoridate
EC Number:
643-080-8
Cas Number:
24389-25-1
Molecular formula:
LiPO2F2
IUPAC Name:
Lithium phosphorodifluoridate
Test material form:
solid: particulate/powder
Details on test material:
Batch number: 250407K2

Test animals

Species:
rabbit
Strain:
other: Japanese White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kitayama LABES Co., Ltd
- Age at study initiation: 11 weeks old
- Weight at study initiation: 2.51 - 2.64 kg
- Housing: Hanging type aluminium cages (32W x 48D x 33H cm, stainless steel mesh flooring)
- Diet (e.g. ad libitum): Pellet diet, ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 1 day after 7 day quarantine period

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.9 - 24.1°C
- Humidity (%): 45.1 - 63.0 %
- Air changes (per hr): 6 - 20
- Photoperiod (hrs dark / hrs light): 12h dark, 12h light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: olive oil
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g test substance

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.15 mL
- Lot/batch no. (if required): 70910
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk
- coverage: approx 6cm2
- Type of wrap if used: semi-occlusive elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours

OBSERVATION TIME POINTS
1, 24, 48, 72 hours then 7, 10, 14 days

SCORING SYSTEM:
- Method of calculation: following the OECD guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
not reversible
Remarks:
eschar formation was observed after 7 days and did not reverse by the end of the 14 day observation period
Remarks on result:
probability of severe irritation
Remarks:
Max score achieved on Day 7, 10 and 14 observations
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other:
Remarks:
no effect
Other effects:
- Other adverse local effects: Irreversible effects to the skin was observed in one animal during the study

Any other information on results incl. tables

No irritation was seen in the control animals (treated with olive oil) all scores zero.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
The substance is concluded to be corrosive/severly irritating to skin and therefore a classification of Skin Corrosion Category 1 is applied.