Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an appropriate OECD test guideline. It was not compliant with GLP.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Nonan-1-ol
EC Number:
205-583-7
EC Name:
Nonan-1-ol
Cas Number:
143-08-8
Molecular formula:
C9H20O
IUPAC Name:
nonan-1-ol
Details on test material:
No data.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
No data.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: undiluted (and as 50% solution in PEG400)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL

- Concentration (if solution): Undiluted or 50% in PEG.
Duration of treatment / exposure:
4 hour(s)
Observation period:
72 hours
Number of animals:
6
Details on study design:
TEST SITE

- Application under exposure chamber of 6cm2.

REMOVAL OF TEST SUBSTANCE

-Not reported.

SCORING SYSTEM: Draize

Results and discussion

In vivo

Irritant / corrosive response data:
See table 1 and 2.
Other effects:
None reported.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test. Undiluted test substance.

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 2

60 min (group mean)

0.8

0

24 h (group mean)

 1.8

0

48 h (group mean)

 2.4

0

72 h (group mean)

 2.4

0

Average 24h, 48h, 72h

 2.2

0

Reversibility*)

Average time (unit) for reversion

 -

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible#

Table 2: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test. 50%nonanolin PEG400.

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 2

60 min (group mean)

0.8

0.2

24 h (group mean)

 1.8

0.2

48 h (group mean)

 2.0

0.4

72 h (group mean)

 2.0

0

Average 24h, 48h, 72h

 1.9

0.2

Reversibility*)

Average time (unit) for reversion

 -

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 (individual animal scores were not reported)

 

 

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A mean erythema score of 2.2 was determined in a reliable study conducted according to an appropriate test protocol. The study was not in compliance with GLP.