Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982-04-13 to 1982-07-12
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study similar to guideline. Limited substance information (e.g. purity) and reversibility of effects not fully assessed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
In the preliminary test, albino Wistar rats are administered the test substance to intact, uncovered, clipped dorsal skin, undiluted and at concentrations of 30% and 10%. Observations of the treatment site were made for up to 72 hours. In a subsequent phototoxicity test, a 30% solution of the test substance was applied, with and without a period of exposure to light.
GLP compliance:
not specified
Remarks:
The study pre-dates the introduction of GLP in the United Kingdom

Test material

Constituent 1
Reference substance name:
2-n-hexyl cyclopentanone
IUPAC Name:
2-n-hexyl cyclopentanone
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): 2-n-hexyl cyclopentanone
- Substance type: no data.
- Physical state: no data.
- Analytical purity: no data.
- Impurities (identity and concentrations): no data.
- Composition of test material, percentage of components: no data.
- Isomers composition: no data.
- Purity test date: no data.
- Lot/batch No.: 5.12947T1
- Expiration date of the lot/batch: no data.
- Stability under test conditions: no data.
- Storage condition of test material: refrigerated.

Test animals

Species:
rat
Strain:
Wistar
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: "Colworth colony".
- Age at study initiation: no more than 29 days.
- Weight at study initiation: at least 35 g (at weaning).
- Housing: individually, in cages with wire mesh floors.
- Diet (e.g. ad libitum): ad libitum access to pelleted commercial rat diet.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: no data.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data.
- Humidity (%): no data.
- Air changes (per hr): no data.
- Photoperiod (hrs dark / hrs light): no data.

IN-LIFE DATES: no data.

Test system

Type of coverage:
open
Preparation of test site:
clipped
Vehicle:
other: Ethanol
Controls:
other: PRELIMINARY IRRITATION TEST: yes, concurrent vehicle; PHOTOTOXICITY TEST: yes, concurrent no exposure to light.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL.
- Concentration (if solution): PRELIMINARY IRRITATION TEST: 10, 30 and 100%; PHOTOTOXICITY TEST: 30%

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.1 mL.
- Concentration (if solution): not applicable.
- Lot/batch no. (if required): no data.
- Purity: no data.
Duration of treatment / exposure:
Up to 72 hours. The methods detailed in the study report do not mention any washing or other removal of the test substance in the preliminary irritation test.
Observation period:
Up to 72 hours.
Number of animals:
PRELIMINARY IRRITATION TEST: 5 rats/concentration.

PHOTOTOXICITY TEST: 10 rats/group.
Details on study design:
TEST SITE
- Area of exposure: "spread across the clipped dorsum of each rat".
- % coverage: no data.
- Type of wrap if used: not applicable.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed.
- Time after start of exposure: not applicable.

SCORING SYSTEM: treatment sites were assessed for erythema, oedema, cracking, scaling, dryness, haemorrhage, ulceration, scabbing and exudation on a 9-point scale. 0 = absent; 1 = very slight; 2 = slight; 3 = slight to distinct; 4 = distinct; 5 = distinct to well developed; 6 = well developed; 7 = well developed to severe; 8 = severe.

LIMITATIONS: The reversibility of the graded effects was not assessed in this study; scores were only recorded up to 72 hours after administration.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: Mean of 24, 48 and 72 hour gradings.
Score:
2
Max. score:
8
Reversibility:
no data
Remarks on result:
other: Result of preliminary irritation test, group A (undiluted test substance).
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: Mean of 24, 48 and 72 hour gradings.
Score:
3.7
Max. score:
8
Reversibility:
no data
Remarks on result:
other: Result of preliminary irritation test, group A (undiluted test substance).
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: Mean of 24, 48 and 72 hour gradings.
Score:
1.3
Max. score:
8
Reversibility:
no data
Remarks on result:
other: Result of preliminary irritation test, group A (undiluted test substance).
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: Mean of 24, 48 and 72 hour gradings.
Score:
2.3
Max. score:
8
Reversibility:
no data
Remarks on result:
other: Result of preliminary irritation test, group A (undiluted test substance).
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: Mean of 24, 48 and 72 hour gradings.
Score:
2.3
Max. score:
8
Reversibility:
no data
Remarks on result:
other: Result of preliminary irritation test, group A (undiluted test substance).
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: Mean of 24, 48 and 72 hour gradings.
Score:
3
Max. score:
8
Reversibility:
no data
Remarks on result:
other: Result of preliminary irritation test, group A (undiluted test substance).
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: Mean of 24, 48 and 72 hour gradings.
Score:
2.3
Max. score:
8
Reversibility:
no data
Remarks on result:
other: Result of preliminary irritation test, group A (undiluted test substance).
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: Mean of 24, 48 and 72 hour gradings.
Score:
3.3
Max. score:
8
Reversibility:
no data
Remarks on result:
other: Result of preliminary irritation test, group A (undiluted test substance).
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: Mean of 24, 48 and 72 hour gradings.
Score:
1.7
Max. score:
8
Reversibility:
no data
Remarks on result:
other: Result of preliminary irritation test, group A (undiluted test substance).
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: Mean of 24, 48 and 72 hour gradings.
Score:
2.7
Max. score:
8
Reversibility:
no data
Remarks on result:
other: Result of preliminary irritation test, group A (undiluted test substance).
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: Mean of 24, 48 and 72 hour gradings.
Score:
1.9
Max. score:
8
Reversibility:
no data
Remarks on result:
other: Result of preliminary irritation test, group A (undiluted test substance).
Irritation parameter:
edema score
Basis:
mean
Time point:
other: Mean of 24, 48 and 72 hour gradings.
Score:
2.7
Max. score:
8
Reversibility:
no data
Remarks on result:
other: Result of preliminary irritation test, group A (undiluted test substance).
Irritant / corrosive response data:
In the preliminary irritation test, using undiluted test material, individual erythema scores (taken as the mean of the 24, 48 and 72 hour gradings) ranged from 1.3 to 2.3. Individual oedema scores ranged from 2.3 to 3.7. In all cases, scores were reported out of a maximum of 8. Based on the descriptions of each value in the scoring system, these results are indicative of a slight irritant.

The investigators considered the 30% solution (in ethanol) to be "minimally irritant" for the purposes of a dose to be carried forward into the phototoxicty study.

Any other information on results incl. tables

Other effects graded in study report for preliminary irritation test, group A (undiluted test substance):

 Animal  Cracking score (max. 8)  Scaling score (max. 8)  Scabbing score (max. 8)
 Animal #1  3 2.3  0.7 
 Animal #2  1.7 2.3  0.3 
 Animal #3  2.3 3  0.3 
 Animal #4  3 3  1 
 Animal #5  2.7 2.7  1 
 Mean  2.5 2.7 0.7 

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: description of scoring system in study report.
Conclusions:
An application (0.1 mL) of undiluted Jasmatone (2-n-hexyl cyclopentanone) was found to be slightly irritating to the skin of rats..
Executive summary:

In an in vivo study, conducted prior to the introduction of GLP or the applicable OECD test guideline, undiluted Jasmatone (2 -n-hexyl cyclopentanone, 0.1 mL) was applied to the skin of 5 Wistar rats. No details on length of application were reported, but the treatment site was apparently left uncovered during the 72 hour observation period.

Mean erythema and oedema scores of 1.9 and 3 (out of 8) were reported for the treated group, expressed as a mean of the 24, 48 and 72 hour gradings. According to the scoring system in the report, this represented a slight irritant. Other effects reported included cracking (mean score 2.5/8), scaling (2.7/8) and scabbing (0.7/8) of the skin. Reversibility of effects not fully assessed.

Categories Display