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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose:
reference to same study
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
See read-across justification attached in section 13.2
Reason / purpose:
read-across source
Related information:
Composition 1
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Test material information:
Composition 1
Specific details on test material used for the study:
- Name of test material (as cited in study report): Tetrahydrogeraniol
- Physical state: colourless liquid
- Storage condition of test material: in the dark at room temperature
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gorseside Rabbits, Gorse, Northchurch, Berkhamsted, Hertfordshire
- Housing: individually housed in grid bottomed metal cages
- Diet: ad libitum antibiotic free rabbit diet (SQC standard rabbit pellets produced by Special Diets Services, Witham, Essex)
- Water: drinking water, ad libitum
- Acclimation period: 18 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-21
- Humidity (%): 37-68
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
- Amount(s) applied: 0.5 ml
- Concentration: 100 %
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: clipped dorsal skin
- Type of wrap if used: compound applied to 2.5 cm square of surgical lint

REMOVAL OF TEST SUBSTANCE
- Washing (if done): cotton wool soaked in water at 37°C.
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to OECD guideline

EVALUATION:
- Time schedule: 1, 24, 48, 72 h, 7 , 14 days after patch removal
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.9
Max. score:
4
Reversibility:
not fully reversible within: 14 days in 2/3 animals
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days (1/3 animals); 14 days (2/3 animals)
Irritant / corrosive response data:
See table 1.

Table 1:

A well defined irritation which was significant at day 7 was noted.

Recovery had generally occured within 14 days

Readings Animal Erythema Edema Further findings
1h 1 1 0 -
  2 1 1 -
  3 2 1 -
24h 1 2 1 -
  2 1 1 -
  3 2 1 -
48h 1 2 1 -
  2 2 1 -
  3 2 1 -
72h 1 2 1 -
  2 2 1 -
  3 2 1 -
7 d 1 2 1 Marked desquamation
  2 1 0 Marked desquamation
  3 2 2 Marked desquamation
14d 1 1 0 -
  2 0 0 slight desquamation
  3 1 0 -
Mean (24h-72h) 1 2,0 1,0  
  2 1,7 1,0  
  3 2,0 1,0  
Mean (24h-72h) all animals 1,9 1,0  
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
According to the study, the test substance was found to be corrosive and is classified as Category 2.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Name of test material (as cited in study report): Tetrahydrogeraniol
- Physical state: colourless liquid
- Storage condition of test material: in the dark at room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gorseside Rabbits, Gorse, Northchurch, Berkhamsted, Hertfordshire
- Housing: individually housed in grid bottomed metal cages
- Diet: ad libitum antibiotic free rabbit diet (SQC standard rabbit pellets produced by Special Diets Services, Witham, Essex)
- Water: drinking water, ad libitum
- Acclimation period: 18 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-21
- Humidity (%): 37-68
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
- Amount(s) applied: 0.5 ml
- Concentration: 100 %
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: clipped dorsal skin
- Type of wrap if used: compound applied to 2.5 cm square of surgical lint

REMOVAL OF TEST SUBSTANCE
- Washing (if done): cotton wool soaked in water at 37°C.
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to OECD guideline

EVALUATION:
- Time schedule: 1, 24, 48, 72 h, 7 , 14 days after patch removal

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.9
Max. score:
4
Reversibility:
not fully reversible within: 14 days in 2/3 animals
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days (1/3 animals); 14 days (2/3 animals)
Irritant / corrosive response data:
See table 1.

Any other information on results incl. tables

Table 1:

A well defined irritation which was significant at day 7 was noted.

Recovery had generally occured within 14 days

Readings Animal Erythema Edema Further findings
1h 1 1 0 -
  2 1 1 -
  3 2 1 -
24h 1 2 1 -
  2 1 1 -
  3 2 1 -
48h 1 2 1 -
  2 2 1 -
  3 2 1 -
72h 1 2 1 -
  2 2 1 -
  3 2 1 -
7 d 1 2 1 Marked desquamation
  2 1 0 Marked desquamation
  3 2 2 Marked desquamation
14d 1 1 0 -
  2 0 0 slight desquamation
  3 1 0 -
Mean (24h-72h) 1 2,0 1,0  
  2 1,7 1,0  
  3 2,0 1,0  
Mean (24h-72h) all animals 1,9 1,0  

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
According to the study, the test substance was found to be an irritant and is classified as Category 2.