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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Information from review article and whilst the reliability is unknown, the original data are unpublished data from the CTFA. The data presented are detailed and adequate for assessment. Noting the test material is a gas, there are insufficient detail on how the material was applied. Contributes to a weight of evidence assessment.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Final report of the safety assessment of isobutane, isopentane, n-butane and propane
Author:
Anon
Year:
1982
Bibliographic source:
J American College of Toxicology, Volume 1, Number 4, 127-142
Reference Type:
other: submission report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 16 CFR 1500.41
Principles of method if other than guideline:
Several formulations containing isobutane or a propane-isobutane mixture were tested for acute dermal irritation in rabbits according to 16 CFR 1500.41.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Isobutane
EC Number:
200-857-2
EC Name:
Isobutane
Cas Number:
75-28-5
Molecular formula:
C4H10
IUPAC Name:
isobutane
Constituent 2
Chemical structure
Reference substance name:
Propane
EC Number:
200-827-9
EC Name:
Propane
Cas Number:
74-98-6
Molecular formula:
C3H8
IUPAC Name:
propane
Details on test material:
- Name of test material (as cited in study report):Formulations containing propane and isobutane were tested.

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
not specified
Preparation of test site:
shaved
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
The following concentrations of isobutane were tested: 83.20, 74.25, 75.75, 77.75, 80.75, 76.75, 84.55, 89.55, 75.75, 80.40, 78.55, 85.35, 80.75, 80.75 and 79.30%.
The following concentrations of isobutane:propane mixtures were tested: 65.94:12.56, 62.916:11.984, 65.44:12.46, 68.54:13.06, 65.562:12.488, 65.94:12.56%
Duration of treatment / exposure:
No data
Observation period:
72 hours
Number of animals:
6 per concentration
Details on study design:
Isobutane or isobutane:propane mixtures were applied to the shaved, intact skin on the back of each of a group of 6 rabbits. Erythema and oedema were assessed at 24 and 72 hours and the erythema and oedema scores calculated. The primary irritation index (PII) was calculated for each concentration and the skin irritation classified according to the following scheme: PII Score 0-2 = mildly irritating, 2-5 = moderately irritating, 6-8 = severely irritating.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.29 - 2.02
Reversibility:
no data
Remarks on result:
other: at isobutane concentrations ranging from 65.6% to 83.2%
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.38 - 0.86
Reversibility:
no data
Remarks on result:
other: mixtures of isobutane:propane at following concentrations: 65.94:12.56, 62.916:11.984, 65.44:12.46, 68.54:13.06, 65.562:12.488, 65.94:12.56%

Any other information on results incl. tables

Ingredient

Concentration (%)

Primary Irritation Index

Isobutane

83.20

2.025

Isobutane/Propane

65.94/12.56

0.725

Isobutane/Propane

62.916/11.984

0.38

Isobutane/Propane

65.44/12.46

0.42

Isobutane

74.25

1.895

Isobutane

75.75

1.085

Isobutane/Propane

68.54/13.06

0.855

Isobutane

77.75

1.71

Isobutane

80.75

0.315

Isobutane/Propane

65.562/12.488

0.565

Isobutane

76.75

1.435

Isobutane

84.55

0.545

Isobutane

89.55

0.52

Isobutane/Propane

65.94/12.56

0.425

Isobutane

75.75

1.19

Isobutane

80.40

0.45

Isobutane

78.55

0.520

Isobutane

85.35

0.75

Isobutane

80.75

1.19

Isobutane

80.75

1.44

Isobutane

79.30

0.29

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU (DSD)
Conclusions:
When formulations containing isobutane (65.56-83.2%) or isobutane:propane mixtures (62.92-65.94% isobutane,11.984-13.06% propane ) were tested for acute dermal irritation, no to moderate erythema and oedema was seen and they were considered to be mostly mild skin irritants.
Executive summary:

When formulations containing isobutane (65.56-83.2%) or isobutane:propane mixtures (62.92-65.94% isobutane, 11.984 -13.06% propane) were tested for acute dermal irritation, no to moderate erythema and oedema was seen and they were considered to be mostly mild skin irritants.

Information from review article and whilst the reliability is unknown, the original data are unpublished data from the CTFA. The data presented are detailed and adequate for assessment. However, it is noted the test material is a gas and there are insufficient detail on how the material was actually applied.