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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:
key study
Study period:
October 25, 1988 - October 28, 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study performed according to GLP and OECD Guideline READ ACROSS To address toxicological endpoints as part of the REACH registration of Lemonile (Target Substance) it is proposed to read-across to Citronellyl Nitrile (Source Substance). The use of read-across works within the spirit of REACH and the stated aim of the legislation to reduce animal testing where possible. The Target Substance and Source Substance have been characterised in using the categories and databases present in the OECD [Q]SAR Toolbox. From the profiling in this table, it can be seen that the two substances share structural similarities and also ‘mechanistic action’ similarities which are both general and endpoint specific. Therefore read across is justified.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report):88-214-01
- Physical state: Liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Products, Inc. Denver, PA
- Weight at study initiation: Refer to Table 3 in results section
- Housing: Rabbits were housed individually in cages sized in accordance with the " Guide for the Care and Use of Laboratory Animals" of the Institute of Laboratory Resources, National Research Council.
- Diet: Wayne Rabbit Ration ad libitum
- Water: Fresh tap water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C ± 3°C
- Humidity: 30 to 70%:
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: intact
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
72 h
Number of animals:
Four (two males and two females)
Details on study design:
TEST SITE
Test article was administered at one intact site on the dorsal trunk of the animal. Approximately 24 hours prior to the study, all application sites were clipped free of hair. Flowwing the application of the test material, gauze patches were applied to each of the sites then wrapped with a rubber dam and an Ace bandage to retard evaporation.

SCORING SYSTEM:
After patch removal the animals were examined for erythema and edema and scored according to Draize at 30-60 minutes, 24, 48 and 72 hours after patch removal

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: Mean of scores at 24, 48, 72h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: Mean of scores at 24, 48, 72 h
Score:
1
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: Mean of scores at 24, 48, 72 h
Score:
0.67
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: Mean of scores at 24, 48, 72 h
Score:
0.33
Irritation parameter:
erythema score
Basis:
mean
Remarks:
All animals
Time point:
other: Mean of scores at 24, 48 and 72 h
Score:
0.5
Irritation parameter:
edema score
Basis:
animal: # 1,2 3 and 4
Time point:
other: Mean of scores at 24, 48, 72 h
Score:
0
Irritant / corrosive response data:
The pH of the test article was 6. No signs of irritation or corrosion were observed at the 30-60 minute post-dose observation period. Very slight to well-defined erythema was observed in three animals at the 24 hour observation period. Very slight erythema was observed in two animals at the 48 hour observation period. No signs of edema were observed during the study. All scores returned to normal at the 72 hour post-dose observation period and the study was terminated.

Any other information on results incl. tables

Table 1: Dermal irritation observations

Rabbit number

Sex

Observations/post treatment

30-60 minutes

24 hours

Erythema

Edema

Erythema

Edema

8596

0

0

0

0

8597

0

0

2

0

8598

 

0

0

1

0

8599

 

0

0

1

0

Table 2: Dermal irritaiton observations

Rabbit number

Sex

Observations/post treatment

48 hours

72 hours

Erythema

Edema

Erythema

Edema

8596

0

0

0

0

8597

1

0

0

0

8598

 

1

0

0

0

8599

 

0

0

0

0

Table 3: Weight (kg)

Rabbit number

Sex

Initial

Final

8596

3.709

3.853

8597

3.277

3.403

8598

 

3.273

3.387

8599

 

3.830

3.890

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not considered to be irritating to skin according to CLP Regulation (EC) no. 1272/2008.