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

Skin irritation / corrosion

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tetrabutan (dest.)

IUPAC Name:

Tetrabutan (dest.)

Details on test material:

- Name of test material (as cited in study report): Tetrabutan (dest.)
- Physical state: liquid
- Isomers composition: C16-(branched), C20-(branched) and C24-(branched)-alkanes

Test animals

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

Test system

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

Results and discussion

In vivo

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24, 48 and 72 hrs

Score:

0.67

Max. score:

4

Reversibility:

fully reversible

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24,48 and 72 hrs

Score:

0

Max. score:

4

Any other information on results incl. tables

 

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

Applicant's summary and conclusion

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.