Reaction mass of 2-butylheptanoic acid and 2-ethylnonanoic acid and 2-methyldecanoic acid and 2-propyloctanoic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study, category approach

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

940-601-3

EC Number:

940-601-3

IUPAC Name:

940-601-3

Constituent 2

Reference substance name:

Reaction mass of n-undecanoic-acid and 2-methyl-decanoic-acid and 2-ethyl-nonanoic-acid and 2-propyl-octanoic-acid and 2-butyl-heptanoic-acid

IUPAC Name:

Reaction mass of n-undecanoic-acid and 2-methyl-decanoic-acid and 2-ethyl-nonanoic-acid and 2-propyl-octanoic-acid and 2-butyl-heptanoic-acid

Details on test material:

- Name of test material (as cited in study report): Reaction mass of n-undecanoic-acid and 2-methyl-decanoic-acid and 2-ethyl-nonanoic-acid and 2-propyl-octanoic-acid and 2-butyl-heptanoic-acid (Isocarb L 11)
- Physical state: liquid
- Analytical purity: 97.6%
- Storage condition of test material: at room temperature, protected from light
- Expiration date of the lot/batch: 2014-10-01

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, 97633 Sulzfeld, Germany
- Age at study initiation: approximately 10-11 weeks old (animals no. 1 and 2), 18 - 19 weeks old (animal no. 3)
- Weight at study initiation: > 2 kg
- Housing: individually housed in ABS-plastic rabbit cages, floor 4200 cm²
- Diet: Altromin 2123 maintenance diet for rabbits (lot no 0650), rich in crude fibre and autoclaved hay, ad libitum
- Water: tap water (drinking water, municipal residue control, microbiological controls at regular intervals) ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 2014-03-09 To: 2014-04-14

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: The untreated other side served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL per test site

Duration of treatment / exposure:

4 hours

Observation period:

Animal no. 1 was observed for 10 days after patch removal, animals no. 2 and 3 were observed for 14 days after patch removal.

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: approx. 6 cm² of shaved skin on one side of the dorsal area
- % coverage: not mentioned
- Type of wrap if used: gauze patch, which was held in place with non-irritating tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, the residual test item was removed with tap water
- Time after start of exposure: 4 hours


SCORING SYSTEM: according to guideline

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 10 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

other: desquamation

Reversibility:

not fully reversible within: 14 days in 2 of 3 animals

Irritant / corrosive response data:

Under the conditions of the present study, the single dermal application of the test item to three rabbits at a dose of 0.5 mL showed irritant effects, which were not fully reversible within the observation period in two of three animals.

Animal no. 1: The examination of the test site immediately after the patch removal revealed erythema grade 1 and oedema grade 1. The subsequent clinical observations showed slightly irritant (erythema grade 1, oedema grade 1 and desquamation) effects, which were fully reversible within 10 days.

Animal no. 2 and no. 3: Slightly irritant (erythema grade 1, oedema grade 1) effects were observed 1 hour after patch removal. These irritant effects subsided on days 6 (animal no. 2) resp. 9 (animal no.3). On day 4 until the end of the observation period animals no.2 and 3 showed desquamation of the skin at the application area. These effects were not fully reversible within 14 days.

No corrosive effects were observed on the intact skin of the three female rabbits after a contact time of 4 hours.

Other effects:

Neither mortality nor significant clinical signs of toxicity were observed. There were no significant body weight changes during the contact and observation period.

Any other information on results incl. tables

Table: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Erythema	Edema	Specific local findings (apart from erythema/oedema)*)
	Max. score: 4	Max. score: 4
60 min	1/1/1	1/1/1	nsf/nsf/nsf
24 h	1/1/1	1/1/1	nsf/nsf/nsf
48 h	1/1/1	1/1/1	nsf/nsf/nsf
72 h	1/1/1	1/1/1	des./nsf/nsf
day 4	1/1/1	1/1/1	des./des./des.
day 5	1/1/1	0/0/1	des./des./des.
day 6	1/0/1	0/0/1	des./des./des.
day 7	1/0/1	0/0/0	des./des./des.
day 8	1/0/1	0/0/0	des./des./des.
day 9	1/0/0	0/0/0	nsf/des./des.
day 10	0/0/0	0/0/0	nsf/des./des.
day 11	-/0/0	-/0/0	-/des./des.
day 12	-/0/0	-/0/0	-/des./des.
day 13	-/0/0	-/0/0	-/des./des.
day 14	-/0/0	-/0/0	-/des./des.
Average 24h, 48h, 72h	1.0	1.0	-
Reversibility**)	c.	c.	n.c.
Average tine for reversion	10 days	7 days	-

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

nsf = no specific findings, des. = desquamation

 

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the present study, the single dermal application of the test item to three rabbits at a dose of 0.5 mL showed slightly irritant effects in all animals directly after patch removal, which were fully reversible within 10 days. Later on (animal no. 1 after 72 h, resp. on day 4 animals no. 2 and 3) desquamation of the skin at the application area were noted. These effects were not fully reversible within 14 days in 2 of 3 animals. No corrosive effects were observed in any animal at any observation time. Neither mortalities nor significant clinical signs of toxicity were observed.

Executive summary:

Under the conditions of the present study, the single dermal application of the test item to three rabbits at a dose of 0.5 mL showed irritant effects, which were not fully reversible within the observation period in two of three animals. Therefore the substance Reaction mass of n-undecanoic-acid and 2-methyl-decanoic-acid and 2-ethyl-nonanoic-acid and 2-propyl-octanoic-acid and 2-butyl-heptanoic-acid is an skin irritant Category 2 and the H-Phrase H315 has to be used.