2-chlorobutane

Endpoint summary

Description of key information

Skin irritation/corrosion: non-irritant
Eye irritation/damage: non-irritant
respiratory irritation: no data available

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:

1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented, according to accepted guidelines

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

-reliability scoring based on 2002 guideline

Deviations:

yes

Remarks:

-purity of the test article and sex of the animals were not reported

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

-purity of the test article and sex of the animals were not reported

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm, D-2740 Bremervorde, Neuendamm 88
- Age at study initiation: not reported
- Weight at study initiation: 2.4 to 2.8 kg
- Housing: Individually
- Diet (e.g. ad libitum): pellets (Ssniff MU Z, Ssniff Spezialdiaten GmbH); ad libitum
- Water (e.g. ad libitum): drinking water; ad libitum
- Acclimation period: at least 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 2
- Humidity (%): 50 to 85
- Photoperiod (hrs dark / hrs light):12/12

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- pH was 6.5

Duration of treatment / exposure:

4 hours

Observation period:

30 to 60 minutes, 24, 48, and 72 hours

Number of animals:

3 animals

Details on study design:

TEST SITE
- Area of exposure: ca. 6 cm squared on the back of each animals
- Type of wrap if used: semi-occlusive dressing, which was held in place by non-irritating tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the exposure period, the dressing was removed and any residual sample was carefully washed away with water or an appropriate solvent.
- Time after start of exposure: 4h

SCORING SYSTEM: Same scale as the one provided in the OECD guideline

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 30 to 60 min

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 hr

Score:

1

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 48 hr

Score:

1

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 hr

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 30 to 60 min

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 hr

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 48 hr

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72 hr

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In this skin irritation/corrosion test sec-butylchloride was shown to be non irritant as defined by CLP (Regualtion (EC) 1272/2008).

Executive summary:

In this skin irritation/corrosion test according to OECD 404 sec-butylchloride was shown to be non irritant as defined by CLP (Regualtion (EC) 1272/2008). Only after 24 and 48 hours very slight erythema (barely perceptible) were noted and these were fully reversible, not observed at 72 hr. following application.

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:

1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented, according to accepted guidelines

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

reliability scoring based on 2002 guideline

Deviations:

yes

Remarks:

Six rabbits were tested in total and three of the test eyes were washed following administration

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm, D-2740 Bremervorde, Neuendamm 88
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: Individually
- Diet (e.g. ad libitum): ad libitum, Ssniff Mu Z (pellets), Ssniff Spezialdiaten GmbH
- Water (e.g. ad libitum): ad libitum, drinking water
- Acclimation period: At least 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 2°C
- Humidity (%): 50 to 85%
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Undiluted
- Ph was 6.5

Duration of treatment / exposure:

0.1 mL of the test material was placed into the conjunctival sac of the left eye while the right eye served as control.

Observation period (in vivo):

1, 24, 48, and 72 hour after treatment

Number of animals or in vitro replicates:

3 animals in total

Details on study design:

SCORING SYSTEM:
Cornea opacity- degree of density (area most dense taken for reading): Grade

No ulceration or opacity: 0
Scattered or diffused areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible: 1
Easily discernible translucent areas, details of iris slightly obscured: 2
Nacreous areas, no details of iris visible, size of pupil barely discernible: 3
Opaque cornea, iris not discernible through the opacity: 4

Iris: Grade

Normal: 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of these or combination of any thereof, iris still reacting to light: 1
No reaction to light, haemorrhage, gross destruction (any or all of these): 2

Conjunctivae Redness (refers to the most severe reading of palpebral and bulbar conjunctivae, cornea, and iris): Grade

Blood vessels normal: 0
Some blood vessel definitely hyperaemic (injected): 1
Diffuse, crimson colour, individual vessels not easily discernible: 2
Diffuse beefy red appearance: 3

Chemosis (lids and/or nictating membranes): Grade

No swelling: 0
Any swelling above normal: 1
Obvious swelling with partial eversion of lids: 2
Swelling with lids about half-closed: 3
Swelling with lids more than half-closed: 4


TOOL USED TO ASSESS SCORE: Readings of ocular reactions were made 1, 24, 48, 72 hours after treatment using an ophthalmoscope.

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

3 animals

Time point:

other: 1 hr

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

3 animals

Time point:

other: mean of 24, 48, 72 hrs

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

iris score

Basis:

mean

Remarks:

3 animals

Time point:

other: 1 hr

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Irritation parameter:

iris score

Basis:

mean

Remarks:

3 animals

Time point:

other: mean of 24, 48, 72 hrs

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

3 animals

Time point:

other: 1 hr

Score:

2.3

Max. score:

3

Reversibility:

fully reversible within: 71 hours

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

3 animals

Time point:

other: mean of 24, 48, 72 hrs

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

3 animals

Time point:

other: 1 hr

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 47 hours

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

3 animals

Time point:

other: mean of 24, 48, 72 hrs

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under conditions of this test to investigate eye irritation/corrosion to rabbits 2-chlorobutane was found not to be classfied as irritant to eyes when applying the criteria for classification as described in CLP (Regulation (EC) No 1272/2008), respectively DSD (Directive 67/548/EEC).

Executive summary:

The substance showed a marked conjunctivae redness and chemosis directly after exposure to eyes of rabbits (1 hr following exposure), which quickly reversed after 48 hours. Thus, wehn applying the criteria as described in GHS respectively CLP (Regualtion (EC) No 1272/2008) the substance is not to be classified as having irreversible effects to eyes respectively being irritant to eyes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin corrosion/irritation:

In a well documented OECD404 guideline GLP-study the skin corrosion/irritation potential of 2-chlorobutane has been investigated and the substance was found to be non-irritant to skin. Only very slight erythema effects were seen 24 and 48 hrs following exposure which fully reversed at 72 hrs after exposure. This observation is supported by Smyth et al. that ranked the skin irritation potential with grade 1 out of 10 (a non-Draize scoring system was applied at that time).

Eye damage/irritation:

In a well documented OECD405 guideline GLP-study the eye damage/irritation potential of 2-chlorobutane has been investigated and the substance was found to be non-irritant to eyes. Conjunctiva redness and chemosis was marked directly following exposure but quickly reversed, disappearing entirely 72 hours following exposure. The mean scores were 1.0 for conjunctivae redness (mean of 24, 48 and 72 hours following exposure as required by CLP for assessment) and 0.33 for chemosis (mean of 24, 48 and 72 hours following exposure as required by CLP for assessment) and thus the substance is not subject to classification as irritant according to CLP. This observation is supported by Smyth et al. that ranked the eye irritation potential with grade 2 out of 10 (a non-Draize scoring system was applied at that time).

Justification for selection of skin irritation / corrosion endpoint:
Well documented OECD404 GLP-study

Justification for selection of eye irritation endpoint:
Well documented OECD405 GLP-study

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

2 -Chlorobutane has been investigated for skin irriation / corrosion and eye irritation /damage in 2 studies each. All results were found to be outside the boundaries for classifciation and labelling according to CLP (Regulation (EC) No 1272/2008) and DSD (Directive 67/548/EEC) and thus the substance is not classifiable for skin irritation/corrosion or eye irritation/damage.

As no data is available to assess respiratory irritation, the substance is not classifiable for this endpoint.