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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:
1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was not performed under GLP compliance, however, the study was conducted according to standards of that time, therefore the study is considered to be adequate, reliable and relevant.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1957
Report date:
1957

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: FHSA, 16cfr1500.41 CPSC
Principles of method if other than guideline:
FHSA: Federal Hazardous Substances Act
CPSC: Consumer Product Safety Commission
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 1,4-bis(1,3-dimethylbutyl) sulphonatosuccinate
EC Number:
219-147-9
EC Name:
Sodium 1,4-bis(1,3-dimethylbutyl) sulphonatosuccinate
Cas Number:
2373-38-8
Molecular formula:
C16H30O7S.Na
IUPAC Name:
sodium 1,4-bis[(4-methylpentan-2-yl)oxy]-1,4-dioxobutane-2-sulfonate
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): Aerosol MA-80%, sodium dihexylsulfosuccinate
- Physical state: Clear, viscous liquid (80% solution)
- Analytical purity: 78-80%
- Impurities (identity and concentrations): See confidential details
- Composition of test material, percentage of components: See confidential details
- Purity test date: Not provided
- Lot/batch No.: BV-1193A NH
- Expiration date of the lot/batch: Not provided
- Stability under test conditions: good stability in aqueous solution
- Storage condition of test material: Not provided

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
Not provided

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
2.5, 5 and 10 mL/kg bw (corresponding to +- 9, 18 and 36 mL or gram)
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
13

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1 (H815)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided; 3 days to death)
Irritation parameter:
erythema score
Basis:
animal: #2 (H817)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided; 2 days to death)
Irritation parameter:
erythema score
Basis:
animal: #3 (H818)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided; 2 days to death)
Irritation parameter:
erythema score
Basis:
animal: #4 (H819)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided; less than 1 day to death)
Irritation parameter:
erythema score
Basis:
animal: #5 (H821)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided; less than 1 day to death)
Irritation parameter:
erythema score
Basis:
animal: #6 (H823)
Time point:
other: not specifed
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided; 7 days observation (survived))
Irritation parameter:
erythema score
Basis:
animal: #7 (H824)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided; 4 days to death)
Irritation parameter:
erythema score
Basis:
animal: #8 (H825)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided; 7 days observation (survived))
Irritation parameter:
erythema score
Basis:
animal: #9 (H826)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided; 7 days observation (survived))
Irritation parameter:
erythema score
Basis:
animal: #10 (H832)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided; 7 days observation (survived))
Irritation parameter:
erythema score
Basis:
animal: #11 (H833)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided; 4 days to death)
Irritation parameter:
erythema score
Basis:
animal: #12 (H835)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided; 7 days observation (survived))
Irritation parameter:
erythema score
Basis:
animal: #13 (H836)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided; 7 days observation (survived))
Irritation parameter:
edema score
Basis:
animal: #1 (H815)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided)
Irritation parameter:
edema score
Basis:
animal: #2 (H817)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided)
Irritation parameter:
edema score
Basis:
animal: #3 (H818)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided)
Irritation parameter:
edema score
Basis:
animal: #4 (H819)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided)
Irritation parameter:
edema score
Basis:
animal: #5 (H821)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided)
Irritation parameter:
edema score
Basis:
animal: #6 (H823)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided)
Irritation parameter:
edema score
Basis:
animal: #7 (H824)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided)
Irritation parameter:
edema score
Basis:
animal: #8 (H825)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided)
Irritation parameter:
edema score
Basis:
animal: #9 (H826)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided)
Irritation parameter:
edema score
Basis:
animal: #10 (H832)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided)
Irritation parameter:
edema score
Basis:
animal: #11 (H833)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided)
Irritation parameter:
edema score
Basis:
animal: #12 (H835)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided)
Irritation parameter:
edema score
Basis:
animal: #13 (H836)
Time point:
other: not specified
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: classification (no scoring provided)
Irritant / corrosive response data:
No scores available

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
At the dose of 10 mL test item/kg there was very severe erythema, edema and necrosis of the skin. At 5 and 2.5 mL test item/kg bw, erythema and edema were initially quite severe, but the edema subsided within 24 to 48 hours. Erythema, however, persisted for 4 to 5 days.
Executive summary:

Single doses of the test item containing 80% active ingredient were applied to the closely-clipped skin of male rabbits for 24 hours under occlusion. Doses given were 2.5, 5 and 10 mL test item/kg body weight, corresponding with ca. 9, 18 and 36 g active ingredient. At the dose of 10 mL/kg there was very severe erythema, edema and necrosis of the skin. At 5 and 2.5 mL/kg bw, erythema and edema were initially quite severe, but the edema subsided wihtin 24 to 48 hours. Erythema, however, persisted for 4 to 5 days. The 2 latter doses were considered as worst case situation volumes (9 and 18 g instead of 0.5 g), therefore the substance is considered to be irritating but not corrosive to skin. There were no scores available.