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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Test substance identified by name only. The observation period was only 7 days.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V, EEC Directive 79/831
Version / remarks:
The system described in the Official Journal of the European Communities No. L257, 16th September 1983 was used to classify materials (Commission Directive of 29th July 1983 adapting technical progress for the 5th time, Council Directive 67/548/EEC).
Deviations:
yes
Remarks:
The observation period was only 7 days.
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 2,6-dimethyloct-7-en-2-ol and 2,6-dimethyloct-7-en-2-yl formate
EC Number:
915-335-6
Molecular formula:
C11H20O2 C10H20O
IUPAC Name:
Reaction mass of 2,6-dimethyloct-7-en-2-ol and 2,6-dimethyloct-7-en-2-yl formate

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Housing: Animals were individually housed in anodised aluminum cages with grid floors and no bedding materials were provided in the cages.
- Diet: Ad libitum (commercially available pelleted rabbit diet (Product Ref. 680, Dalgety-Spillers Ltd.))
- Water: Ad libitum (tap water)
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 40-67
- Air changes (per hr): Not indicated, but room was air-conditioned
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: Tested either undiluted or as 50% solution in DEP
Controls:
no
Amount / concentration applied:
A 0.5 mL aliquot of the test material was placed evenly over a 2.5 cm square of surgical lint B.P. The lint square was then placed onto the animals skin, on the left flank and immediately caudal to the last rib, with the test material in contact with the skin. In the test, a second test material was applied in the same manner to the right flank. Lint patches were held in place with Elastoplast bandages (10 cm wide). The test material was applied a group of four animals either neat (undiluted) or as a 50% solution.
Duration of treatment / exposure:
4 hours. After the treatment period, the adhesive tapes was removed and the treated sites cleansed by gently swabbing with cotton wool soaked in warm water.
Observation period:
One hour after removeal and at 4, 24, 48, 72 and 168 hours after patch removal, animals were assessed for signs of reaction to treatment. Animals were examined under a standard light source designed to comply with the requirements of B.S. 950 Part 1 (Artificial Daylight for the Assessment of Colour). Irritation was assessed numerically as defined in Table 1.
Number of animals:
4
Details on study design:
The day before treatment, rabbits were restrained and the dorsal surfaces of the trunk clipped free of hair using a Oster Model A2 clipper with Angra blade. Groups of 4 healthy animals with intact skin were selected for the study.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: 100% dimyrcetol
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: 100% dimyrcetol
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: 100% dimyrcetol
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: 100% dimyrcetol
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 100% dimyrcetol
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 100% Dimyrcetol
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: 100% dimyrcetol
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.6
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: 100% dimyrcetol
Irritant / corrosive response data:
Sample 8A (50% Dimyrcetol, See Table 2)

Well defined erythema and very slight oedema of the skin were apparent in 3/4 rabbits and very slight erythema in 1/4 rabbits 1 hour after dosing. Some increase in severity of oedematous response was exhibited by 2/4 animals at 24 hours, with slight reaction observed. Further increases in response were apparent at the 48 hour examination with well defined erythema noted in all 4 rabbits. Oedema of the skin ranged from very slight in one rabbit, slight in two rabbits, and moderate in one rabbit. Slight desquamation of the surface of treated skin was also observed in one rabbit. The irritant response seen in one rabbit had declined by the 72 hour observation, with very slight erythema remaining. There were no remaining reactions at treated sites on any rabbit by day 7 after dosing.

Sample 8B (100% Dimyrcetol, See Table 3)

Well defined erythema was observed in all 4 rabbits and very slight oedema of the treated skin in three rabbits was apparent at the one hour observation. Oedematous responses increased and at 24 hours after dosing slight reaction was observed in three rabbits and very slight reaction was noted in the remaining rabbit of the group. Well defined erythema and slight oedema were present at the treated site of all four rabbits 48 and 72 hours after dosing. This response had declined within 7 days with very slight erythema remaining in 3 rabbits and very slight oedema in all 4 rabbits. Slight desquamation from the treated skin was also observed in one rabbit.

Any other information on results incl. tables

Table 2:  Sample 8A Results


 


























































































































































































Rabbit No.


/Observation Time



Erythema Score



Oedema Score



Comments



 



 



 



 



909



 



 



 



1 hour



2



1



 



24 hour



2



2



 



48 hour



2



3



 



72 hour



2



3



 



168 hour



0



0



 



 



 



 



 



914



 



 



 



1 hour



1



0



 



24 hour



1



0



 



48 hour



2



1



Slight desquamation



72 hour



1



0



Very slight desquamation



168 hour



0



0



 



 



 



 



 



915



 



 



 



1 hour



2



1



 



24 hour



2



1



 



48 hour



2



2



 



72 hour



2



2



 



168 hour



0



0



 



 



 



 



 



917



 



 



 



1 hour



2



1



 



24 hour



2



2



 



48 hour



2



2



 



72 hour



2



2



 



168 hour



0



0



 



 



 



 



 



 


Table 3:  Sample 8B Results


 


























































































































































































Rabbit No.


/Observation Time



Erythema Score



Oedema Score



Comments



 



 



 



 



909



 



 



 



1 hour



2



0



 



24 hour



2



2



 



48 hour



2



2



 



72 hour



2



2



 



168 hour



0



1



 



 



 



 



 



914



 



 



 



1 hour



2



1



 



24 hour



2



1



 



48 hour



2



2



 



72 hour



2



2



 



168 hour



1



1



Slight desquamation



 



 



 



 



915



 



 



 



1 hour



2



1



 



24 hour



2



2



 



48 hour



2



2



 



72 hour



2



2



 



168 hour



1



1



 



 



 



 



 



917



 



 



 



1 hour



2



1



 



24 hour



2



2



 



48 hour



2



2



 



72 hour



2



2



 



168 hour



1



1



 



 



 



 



 



 

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Undiluted dimyrcetol is rated as a skin irritant in the rabbit.
Executive summary:

In a key study in rabbits, the undiluted analogue chemical, dimyrcetol, applied under semi-occlusive wrap was rated a skin irritant according to Annex V of EEC Directive 78/831 based on a group mean erythema irritation score of 2 or higher for the 24-, 48- and 72-hour observations. Minimal erythema and edema (scores of 0 to 1) persisted to the 168 hour observation. A 50% dilution in diethyl phthalate was not an irritant under the same conditions. All irritant effects noted in the study with 50% test material were resolved by the 168-hour observation point.