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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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
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
Remarks:
animal 1-6
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal 1-6
Time point:
24/48/72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48
Remarks on result:
no indication of irritation

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