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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Federal Register 38 No 187 § 1500.41 ( Haut) und § 1500.42 (Auge), S. 27019 vom 27.09.73 .
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Study was performed acc. to internal BASF method, which was in large part similiar to OECD 404
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentane-1,5-diol
EC Number:
203-854-4
EC Name:
Pentane-1,5-diol
Cas Number:
111-29-5
Molecular formula:
C5H12O2
IUPAC Name:
pentane-1,5-diol
Details on test material:
- Name of test material (as cited in study report): 1,5-pentanediol

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.70 kg (male); 2.71, 2.72, 3.10, 2.79, 2.80 kg (female)

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact or scarificated
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 ml
- Concentration (if solution): 100%
Duration of treatment / exposure:
20 h
Observation period:
7 d
Number of animals:
1 male, 5 female
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm of back skin
- Type of wrap if used: cotton pad (seize: 2.5 cm x 2.5 cm) saturated with the undiluted test substance (ca. 1 ml)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): 50% Lutrol (polyethylenglycol) dilution in water
- Time after start of exposure: 20 h


SCORING SYSTEM:
Erythema and edema were scored according to the below described system:
Although the results in the report were originally not given as Draize scores the data can be transferred into the Draize scoring system (in brackets). (+) = none - negligible effect (0)
+ = slight effect (1)
++ = moderate effect (2)
+++ = severe effect (>= 3)
N = necrosis

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48

Any other information on results incl. tables

Results:

Animal 1:      female, 2.71 kg

Animal 2:      male, 2.70 kg

Animal 3:      female, 2.72 kg

Animal 4:      female, 3.1 kg

Animal 5:      female, 2.79 kg

Animal 6:      female, 2.80 kg

intact scarificated
Readings Animal Erythema Edema Additional findings Erythema Edema Additional findings
24 h 1 2 1   2 2  
2 2 0   2 1  
3 2 0   2 2  
4 2 0   2 2  
5 1 0   2 2  
6 2 0   2 2  
48 h 1 0 0   2 1  
2 0 0   2 1 p
3 0 0   2 0 p
4 0 0   2 1  
5 0 0   1 0  
6 0 0   1 0  
72 h 1 0 0   1 1  
2 0 0   1 0  
3 0 0   1 0
4 0 0   1 0 d
5 0 0   1 0 d
6 0 0   1 0 d
7 d 1 0 0   0 0 d
2 0 0   0 0  
3 0 0   0 0  
4 0 0   0 0 d
5 0 0   0 0 d
6 0 0   0 0 d
Mean 24 - 72 h 1 0.7 0.3   1.7 1.3  
2 0.7 0.0   1.7 0.7  
3 0.7 0.0   1.7 0.7  
4 0.7 0.0   1.7 1.0  
5 0.3 0.0   1.3 0.7  
6 0.7 0.0   1.3 0.7  
Mean   0.6 0.1 1.6 0.8

D: desquamation

p: spotted appearance

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU