[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Remarks:

in vivo study was conducted prior to REACH implementation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994-12-08 - 1994-12-19 (experimental phase)

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

OECD-Guideline for Testing of Chemicals, Section 4, 404 "Acute Dermal Irritation / Corrosion", adopted July 17, 1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Amines, C11-13 (branched) alkyl, salts with O,O-bis(2-ethylhexyl) hydrogen dithiophosphate

Molecular formula:

C27H60NPS2O2 C28H62NPS2O2 C29H64NPS2O2 (main component)

IUPAC Name:

Amines, C11-13 (branched) alkyl, salts with O,O-bis(2-ethylhexyl) hydrogen dithiophosphate

Test material form:

liquid

Details on test material:

Before Substance ID change known as CAS 71888-91-0 EC 276-159-7

Test animals

Species:

rabbit

Strain:

other: Albino

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. Zimmermann, Schweizer Hof, D-73453 Untergröningen/Aalen
- Age at study initiation: young
- Housing: The rabbits housed individually in wire grating cages (area 2450 cm², height 42 cm) without bedding.
- Diet (e.g. ad libitum): Raiffeisen-Ringfutter, Kaninchen Trockenfutter 52/P, Raiffeisen Kraftfutterwerk Kehl, ad libitum.
- Water (e.g. ad libitum): Community tap water from Karlsruhe; free access for the animals by daily changing of the watering-bottles.
- Acclimation period: The animals were acclimated to the test conditions for 5 days prior to the administration.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23 ° C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES:
Acclimatization: December 08 1994 - December 12, 1994
Administration: December 13 1994
Observation: December 13,1994 - December 19 1994

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Remarks:

On the fifth day the dorsal area of the trunk was shaved in an area of 3 x 5 cm².

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 / animal
- Concentration (if solution): undiluted

Duration of treatment / exposure:

4h

Observation period:

1 week

Number of animals:

3 animals, Identification numbers: 009 (male), 015 and 022 (female)

Details on study design:

TEST SITE
- Area of exposure: The test substance was dermally applied in a single dose of 0.5 ml/animal onto the dorso-lumbar region of 3 albino rabbits.
- Type of wrap if used: The region treated was protected with the non-stripped, non-irritating plastic material of the reverse of a patch (width 6 cm) (Werovil, No. 15 00 20 WERO-MEDICAL, D-65232 Taunusstein). It was held in place for a period of 4 hours by an occlusive bandage made from a dressing (width 8 cm, with selvages, coated completely with cellophane) (No. 09 00 22 WERO-MEDICAL). The bandage was fixed with 1.25 cm broad strips of Adhesive Tape ST (WERO-MEDICAL).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After removal of the bandage at the end of the exposure period the residual test substance was removed by gently washing with water.
- Time after start of exposure: 4h

OBSERVATION TIME POINTS
1 hour after bandage removal, then daily

SCORING SYSTEM:
- Method of calculation: Evaluation of the Skin Reaction according to table 1 in OECD-Guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.7

Max. score:

2

Reversibility:

fully reversible within: day 4 or 5

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other:

Remarks:

no animal showed any signs of edema

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

Rabbit 015 female

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: day 4 or 5

Remarks on result:

other:

Remarks:

Erythema score was 0 after 1h, each 1 at day 1, 2, and 3, and 0 at day 5 and 6

Results 4

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

Rabbit 022 female

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

Rabbit 009, male

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: day 4 or 5

Remarks on result:

other:

Remarks:

Erythema score was 0 after 1h, each 1 at day 1, 2, and 3, and 0 at day 5 and 6

Irritant / corrosive response data:

After removing the occlusive bandage after a period of 4 hours, the exposure area was washed and cleaned with water. In the following observation period a dermal irritation of the exposure area in the form of an erythema (two rabbits) was noticed.
The control area did not show any pathological skin reaction. According to table 1 of OECD-Guideline 404 at all times of evaluation the value was classified as 0.

Under the conditions of this experiment the test substance produced skin lesions in the form of an erythema. Two rabbits showed this effect estimated at grade 1 (maximum possible 4). The erythemata were observed from day 1 to day 3. No oedema could be observed during the observation period. The effects observed turned out to be reversible.

Other effects:

Mortality: After the dermal administration of 0.5 ml test item per animal for a period of 4 hours none of the 3 rabbits died during the experiment.
Toxicological symptoms: During the observation period of 6 days none of the animals showed signs of toxicological symptoms.
Behaviour: The reaction of the rabbits treated was quiet and watchful. The behaviour pattern was not different to that of other rabbits which were not in the test.
Body weight: During the experiment the body weight of all three rabbits had an increase.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

This study was performed in compliance with OECD-Guideline 404 under GLP, is well-documented and with sufficient information for classification, the results can hence be considered as reliable. Under the conditions of this experiment the test substance produced skin lesions in the form of an erythema. Two rabbits showed this effect estimated at grade 1 (maximum possible 4). The erythemata were observed from day 1 to day 3. No oedema could be observed during the observation period. The effects observed turned out to be reversible. According to Regulation 1272/2008, a substance must be classified as skin irritant Cat. 2, if i.a.
(1) Mean value of ≥ 2,3 - ≤ 4,0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or
(2) Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling;
Those criteria are not met here, and so the substance does not need to be classified as irritating to the skin.

Executive summary:

This study was performed in compliance with OECD-Guideline 404 "Acute Dermal Irritation/Corrosion" with three albino rabbits under GLP.

Under the conditions of this experiment the test substance produced skin lesions in the form of an erythema. Two rabbits showed this effect estimated at grade 1 (maximum possible 4). The erythemata were observed from day 1 to day 3. No oedema could be observed during the observation period. The effects observed turned out to be reversible.

During the experiment all three rabbits had an increase in weight.

Visible toxicological signs could not be observed; none of the animals died during the observation period.

GHS criteria are not met, the substance does not need to be classified as irritating to the skin.