C16-(branched), C20-(branched) and C24-(branched)-alkanes

Endpoint summary

Description of key information

Acute irritation studies in the rabbit show very slight effects on skin and eyes shortly after application of the test substance, only, which did not meet GHS criteria. 

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:

09. Sept. 1986 - 15. Sept. 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable study report, which meets basic scientific priniciples

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Species:

rabbit

Strain:

other: Kleine weiße Russen, Chbb-SPF

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.1 - 2.3 kg
- Housing: single housing
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1 °C
- Humidity (%): 60 ± 5 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 cm3

Duration of treatment / exposure:

Exposure: 4 hours

Observation period:

1, 24, 48, 72 hours, and 6 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: gauze and polyethylene foil


REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 4 hours


SCORING SYSTEM: according to OECD 404

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of weak irritation

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of mild irritation

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of weak irritation

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24, 48 and 72 hrs

Score:

0.67

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24,48 and 72 hrs

Score:

0

Max. score:

4

 

Animals			1h		24h		48h		72h		6 days
			Eryth.	Edem.	Eryth.	Edem.	Eryth.	Edem.	Eryth.	Edem.	Eryth.	Edem.
1	18701	male	2	1	1	0	0	0	0	0	0	0
2	18883	male	2	1	2	1	1	0	x1	0	0	0
3	18895	male	2	2	1	0	1	0	0	0	0	0
Mean			3.33		1.67		0.67		0.33		0
Irritation index (72h)			1.5

Eryth.: Erythema

Edem.:Edema

x:        blotched

Interpretation of results:

GHS criteria not met

Conclusions:

Under the described test conditions, only slightly irritating effects were recorded early after application, which were reversible. However, the observations did not meet GHS criteria and according to Regulation (EC) 1272/2008 the data are conclusive but not sufficient for classification.

Executive summary:

In an acute skin irritation /corrosion study 0.5 cm3 of Tetrabutan (dest.) was applied onto the shaved skin of 3 rabbits (Kleine weiße Russen, ChBB-SPF, Dr. Karl Thomae GmbH, Biberach). Exposure was occlusive for 4 hours. Animals were then observed for 6 days. Irritation was scored by the Draize scheme, according guideline OECD 404, after 1 h, 24h, 48h, 72h, and 6 days.

During the observation period all animals showed erythema (score 2) and edema (score 1 or 2) at 1 hour after exposure. Symptoms decreased over time and were complete reversible after 6 days.

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:

09. Sept. 1986 - 15. Sept. 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable study report, which meets basic scientific priniciples

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Species:

rabbit

Strain:

other: Kleine weiße Russen, Chbb-SPF

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.1 - 2.3 kg
- Housing: single housing
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1 °C
- Humidity (%): 60 ± 5 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 cm3

Duration of treatment / exposure:

- exposure: 72 h

Observation period (in vivo):

up to 6 days after application

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological NaCl solution
- Time after start of exposure: 72 hours after application


SCORING SYSTEM: scoring system according to Draize


TOOL USED TO ASSESS SCORE: fluorescein

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

AVERAGE SCORE 1 h/24 h/48 h/72 h/ 6 days
- Cornea: 0.0/0.0/0.0/0.0/0.0
- Iris: 0.0/0.0/0.0/0.0/0.0
- Conjunctiva: 1.0/0.0/0.0/0.0/0.0
Descripton of effects: redness of conjunctiva in all 3 animals 1 hour after application

In an eye irritation study 0.1 cm3 of Tetrabutan (dest.) was instilled into the conjunctival sac of the right eye of 3 rabbits (Kleine weiße Russen, Chbb-SPF, Dr. Karl Thomae GmbH, Biberach). Animals were then observed for 6 days. Irritation was scored by the Draize scheme, according guideline OECD 405.

During the observation period the animals showed redness of the conjunctivae only 1 hour after application. No other symptoms were

observed. In this study, Tetrabutan (dest.) is not irritating to eyes based on the mean values of ocular reactions at 24, 48, and 72 hours.

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance showed very slight signs of irritation shortly after application of the test substance only, which did not meet GHS criteria. Thus, according to Regulation (EC) 1272/2008 the data are conclusive but not sufficient for classification.

Executive summary:

In an eye irritation study 0.1 cm3 of Tetrabutan (dest.) was instilled into the conjunctival sac of the right eye of 3 rabbits (Kleine weiße Russen, Chbb-SPF, Dr. Karl Thomae GmbH, Biberach). Animals were then observed for 6 days. Irritation was scored by the Draize scheme, according guideline OECD 405.

During the observation period the animals showed redness of the conjunctivae only 1 hour after application. No other symptoms were observed. In this study, Tetrabutan (dest.) is not irritating to eyes based on the mean values of ocular reactions at 24, 48, and 72 hours.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In an acute skin irritation /corrosion study, 0.5 cm3 of Tetrabutan (dest.) was applied onto the shaved skin of 3 rabbits under an occlusive dressing for 4 hours. Animals were then observed for 6 days. Irritation was scored by the Draize scheme after 1, 24, 48 and 72 hours and 6 days. During the observation period all animals showed erythema (score 2) and oedema (score 1 or 2) at 1 hour after exposure. Reactions decreased over the following 72-hour period, and were completely resolved by Day 6.

In an acute eye irritation study 0.1 cm3 of Tetrabutan (dest.) was instilled into the conjunctival sac of the right eye of 3 rabbits, and observed for 6 days. Irritation was scored using the Draize scheme. During the observation period, the animals showed redness of the conjunctivae at the 1 hour examination. No other irritation responses were observed.

Justification for classification or non-classification

In an acute skin irritation study, the mean scores for erythema and oedema at the 24, 48 and 72 hour examinations for three animals were below the classification threshold for irritancy, and in an acute eye irritation study, effects of treatment were confined to transient redness of the conjunctivae at the 1 hour examination.

Tetrabutan is therefore classified as non-irritant to skin and eyes, according to the classification, labelling and packaging (CLP) regulation (EC) No 1272/2008