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Diss Factsheets

Administrative data

Description of key information

Decahydronaphthalene caused irreversible skin damage upon 4 h exposure. No skin necrosis was noted upon exposure for 3 min (open) or 1 h (semi-occlusive) (Hüls AG, 1989).

Only mild and reversible eye irritation was noted in an in vivo eye irritation test according to OECD 405 (Hüls AG, 1989).

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:
1989-08-22 to 1989-12-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
other: Small white Russian, Chbb-SPF
Details on test animals or test system and environmental conditions:
TEST ANIMALS: 
- Strain: Small white Russian, Chbb-SPF
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Sex: male
- Weight at study initiation: 2.2 - 2.5 kg
- Housing: individually in steinless steel cages
- Food (ad libitum): K4 Alleindiät für Kaninchen, Ssniff Spezialfutter GmbH, 4770 Soest
- Water (ad libitum): tap water
- preparation of testing site 24 h before treatment (shaving, 10 x 10 cm)

ENVIRONMENTAL CONDITIONS:
- Temperature: 20 °C +/- 1 °C
- Humidity: 60 % +/- 5%
- Air changes: 15/ h
- Photoperiod: 12 h dark/ 12 h light
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
4 hour(s)
Observation period:
 1, 24, 48, 72 hours, 6, 8, 10, and 14 days  after patch removal
Number of animals:
3
Details on study design:
ADMINISTRATION/EXPOSURE 
- Area of exposure: 6 cm²
- Total volume applied: 0.5 ml
- Occlusion: mull patch, elastic dressing
- Removal of test substance: washing with warm water
- Additional tests with 1 animal each: 3 minutes open application, 1 hour  semiocclusive application
- Post exposure period: 14 days
EXAMINATIONS
- Examination time points: 1, 24, 48, 72 hours, 6, 8, 10, and 14 days  after patch removal; evaluation based on readings 1-4
- Scoring system: OECD Guideline; evaluation: VCI notes on safety data  sheet and Appendix VI of 79/831/EEC
Irritation parameter:
primary dermal irritation index (PDII)
Score:
7.5
Max. score:
8
Reversibility:
not reversible
Remarks on result:
other: Eschar formation
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
3.33
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 4.00
- Edema: 3.33
REVERSIBILITY: Not reversible. Eschar detached and new skin within 14  days.
OTHER EFFECTS: After a 3-min open application or a 1-hour semiocclusive  application no necrosis was observed.
Conclusions:
In this primary dermal irritation study, the test item was corrosive to the rabbit skin.
Executive summary:

In a primary dermal irritation study 3 Small White Russian, Chbb-SPF rabbits were dermally exposed to 0.5 ml of undiluted test item for 4 hours to the shaved back skin.  Animals then were observed for 14 days.  The formation of necroses was noted, the irritation index was 7.5/8. No necrosis was noted upon exposure duration of 3 min or 1 h. In this study, the test item was corrosive to the rabbit skin.


Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

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:
1989-09-05 to 1989-09-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
other: Small white Russian, Chbb-SPF
Details on test animals or tissues and environmental conditions:
TEST ANIMALS: 
- Strain: Small white Russian, Chbb-SPF
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Sex: male
- Weight at study initiation: 2.2 - 2.5 kg
- Controls: untreated eye
- Housing: individually in stainless steel cages
- Diet (ad libitum): K4 Alleindiät für Kaninchen, Ssniff Spezialfutter GmbH, 4770 Soest
- Water (ad libitum): tap water

ENVIRONMENTAL CONDITIONS:
- Temperature: 20°C +/- 1°C
- Humidity: 60 % +/- 5 %
- Air change: 15/ h
- Photoperiods: 12 h dark/ 12 h light
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
undiluted
Amount applied: 0.1 ml
Duration of treatment / exposure:
72 hour(s)
Observation period (in vivo):
10 days
Number of animals or in vitro replicates:
3
Details on study design:
ADMINISTRATION/EXPOSURE 
- Vehicle: none
- tested for cornea damage with sodium flourescein solution and eye lamp
- rinsed after 72 h with saline solution
- Postexposure observation period: 10 days

EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, 72 hours, 6, 8, and 10 days  after treatment
- Tool used to assess score: sodium fluorescein / ophthalmic lamp /  visual inspections
- Scoring system: Draize (1959); evaluation: VCI notes on safety data  sheet and Appendix VI of 79/831/EEC
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72h
Score:
0
Max. score:
2
Irritation parameter:
other: conjunctivae redness
Basis:
mean
Time point:
other: 24-72h
Score:
0.78
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72 h
Score:
0.44
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 0-8 days
Score:
3.5
Max. score:
110
Reversibility:
fully reversible
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea: 0.0
- Iris: 0.0
- Conjunctivae (Redness): 0.78
- Conjunctivae (Chemosis): 0.44
- Overall irritation score: 3.5/110
DESCRIPTION OF LESIONS: redness, swelling, and slight incrustation of  eyelids
REVERSIBILITY: complete within 8 days except for slight redness of  eyelids in one animal
Conclusions:
In a primary eye irritation study decahydronaphthalene is considered to be not irritating to eyes.
Executive summary:

In a primary eye irritation study 0.1 mL decahydronaphthalene were administered into the conjunctival sac of three male rabbits.


Slight reversible irritation was noted.


Eye irritation index was assessed using Draize scale.


The test was evaluated as follows (average of evaluation at 24, 48 and 72 hours respectively): cornea: 0, iris: 0, conjunctivae: redness: 0.78 and chemosis: 0.44 (mean scores on Draize scale). Therefore, decahydronaphthalene is considered to be not irritating to eyes with an overall irritation index of 3.5/110 (0 - 10 = not irritating).

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the in vivo data, the test item is classified as corrosive according to CLP regulation 1272/2008 (Cat 1C, H314; Causes severe skin burns and eye damage).