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Diss Factsheets

Administrative data

Description of key information

Jasmatone was slightly irritating to the skin and eyes of rabbits following application of the neat material (Unliever, 1982a,b).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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.
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
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.
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.
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.

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 
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982-03-29 - 1982-06-14
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study similar to guideline. Limited substance information (e.g. purity).
Qualifier:
no guideline available
Principles of method if other than guideline:
Undiluted test substance (10 uL) was applied to one eye of each of two rabbits. Eyes were examined before administration, after 15 minutes treatment, and subsequently at daily intervals. Eyes were graded for corneal, conjunctival and iridial damage.
GLP compliance:
not specified
Remarks:
The study pre-dates the introduction of GLP in the United Kingdom.
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: no data.
- Age at study initiation: 8 weeks.
- Weight at study initiation: 1.6 kg (animal 1) and 1.9 kg (animal 2).
- Housing: individually caged, with no "hay, straw, or similar potentially irritant material".
- Diet (e.g. ad libitum): commercially available, pelleted diet available ad libitum.
- 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.
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye of each animal used as control.
Amount / concentration applied:
10 uL of undiluted test substance applied to one eye of each animal.
Duration of treatment / exposure:
Duration of exposure not specified. Study report does not suggest that there was a rinsing step at any point.
Observation period (in vivo):
Up to 21 days. Assessments were stopped if the treated eye was judged to have returned to normal.
Number of animals or in vitro replicates:
Two.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not specified.
- Time after start of exposure: not specified.

SCORING SYSTEM: Please see Attachment 1.

TOOL USED TO ASSESS SCORE: Eyes were examined with the aid of a handtorch for corneal, conjunctival and iridial reactions.
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #1
Remarks:
Animal number 638, male, 8 weeks, 1.6 kg, treated in right eye
Time point:
other: Mean of gradings at 24, 48 and 72 hours.
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: Evaluation stopped after 4 days (96 hour timepoint) as eye had returned to normal.
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Remarks:
Animal number 638, male, 8 weeks, 1.6 kg, treated in right eye
Time point:
other: Mean of gradings at 24, 48 and 72 hours
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: Evaluation stopped after 4 days (96 hour timepoint) as eye had returned to normal.
Irritation parameter:
chemosis score
Remarks:
conjunctivae
Basis:
animal #1
Remarks:
Animal number 638, male, 8 weeks, 1.6 kg, treated in right eye
Time point:
other: Mean of gradings at 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Some swelling was seen (graded 1/4) 15 minutes after administration. Symptoms had evidently subsided before the 24 hour timepoint.
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
Animal number 638, male, 8 weeks, 1.6 kg, treated in right eye
Time point:
other: Mean of gradings at 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable, no effects seen.
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #2
Remarks:
Animal number 640, male, 8 weeks, 1.9 kg, treated in left eye
Time point:
other: Mean of gradings at 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Evaluation stopped after 2 days (48 hour timepoint) as eye had returned to normal.
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Remarks:
Animal number 640, male, 8 weeks, 1.9 kg, treated in left eye
Time point:
other: Mean of gradings at 24, 48 and 72 hours
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Some redness was seen (graded 1/3) 15 minutes after administration. Symptoms had evidently subsided before the 24 hour timepoint.
Irritation parameter:
chemosis score
Remarks:
conjunctivae
Basis:
animal #2
Remarks:
Animal number 640, male, 8 weeks, 1.9 kg, treated in left eye
Time point:
other: Mean of gradings at 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Some swelling was seen (graded 1/4) 15 minutes after administration. Symptoms had evidently subsided before the 24 hour timepoint.
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
Animal number 640, male, 8 weeks, 1.9 kg, treated in left eye
Time point:
other: Mean of gradings at 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable, no effects seen.
Irritant / corrosive response data:
Corneal damage and conjunctivitis in both eyes was only very slight, with complete repair at 3 and 5 days. Thus, undiluted Jasmatone was considered to be only slightly irritant.
Other effects:
No other effects reported.
Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
An application (10 uL) of undiluted Jasmatone (2-n-hexyl cyclopentanone) was found to be slightly irritating to the eyes of two rabbits, with very slight corneal damage and conjunctivitis observed to be fully reversible within 3 and 5 days.
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, 10 uL) was applied to one eye each of two New Zealand White rabbits. No details on length of application were reported and there is no information in the study report on any rinsing step.

The mean scores (taken across the 24, 48 and 72 hour assessments) for corneal opacity, conjunctival redness, chemosis and iridial damage, were <1 for both animals. Very slight corneal damage and conjunctivis was reported, but was fully reversible within 3 and 5 days. Test substance considered slightly irritating.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In an in vivo study, undiluted Jasmatone (2 -n-hexyl cyclopentanone) was found to be slightly irritating to the skin of Wistar rats. 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. The reversibility of these effects was not fully assessed (Unilever, 1982a).

Irritation was, at worst, only slight, in an acute dermal toxicity study in rabbits (Moreno, 1980), guinea pig skin sensitisation studies (Unilever 1982d; 1983) or a human skin sensitisation study (Epstein, 1980).

Slight, transient, eye irritation was seen in three rabbits following instillation of the neat material. All effects were completely reversible within 7 days (Unliever, 1982b,c).

No respiratory irritation study available. However, such effects are unlikely as Jasmatone is only slightly irritating to the skin and eyes of rabbits and its low volatility indicates that significant inhalation is unlikely under anticipated conditions of use.


Justification for selection of skin irritation / corrosion endpoint:
Reliable in vivo study.

Justification for selection of eye irritation endpoint:
Reliable in vivo study.

Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

Based on the results of a reliable in vivo skin irritation study, and supported by data from acute dermal toxicity and skin sensitisation studies, classification under the EU DSD or CLP regulations as a skin irritant is not required.

Similarly, Jasmatone does not meet the criteria for classification as an eye or respiratory tract irritant.