Phosphoric acid, mono- and di-C16-18 (even numbered) alkyl esters, salts with 2,2'-iminodiethanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

in vivo, performed before the 2018

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Phosphoric acid, mixed decyl and octyl esters, compds. with diethanolamine

Cas Number:

68425-57-0

Molecular formula:

not applicable

IUPAC Name:

Phosphoric acid, mixed decyl and octyl esters, compds. with diethanolamine

Test material form:

solid: crystalline

Details on test material:

Name: Phosphoric acid, mixed decyl and octyl esters, compds. with diethanolamine
CAS No.: 68425-57-0
Physical state: white solid at 20 °C (turbid, non-pourable paste)

Specific details on test material used for the study:

Name: Phosphoric acid, mixed decyl and octyl esters, compds. with diethanolamine (Phosphorsaeure (C8-C10-Alkyl)-ester, DEA-Salz)
CAS No.: 68425-57-0 (68186-45-8)
Physical state: white solid at 20 °C (turbid, non-pourable paste)

Test animals

Species:

rabbit

Strain:

other: Kleinrussen, Chbb:HM

Details on test animals or test system and environmental conditions:

Test animals:

Species/strain: rabbits, healthy Kleinrussen, Chbb:HM
Source: Fa. Thomae, Germany
Sex: male
Mean body weight at the beginning of the study: ca. 2460 g

Age at the beginning of the study: 15 months

Number of animals: 3


Housing and Feeding Conditions:

- Temperature: 20 - 25 °C
- Relative humidity: 45 - 70%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: not specified
- Free access to Altromin-Haltungsdiät 2023
- Free access to tap water (drinking water)
- single-housed animals
- Adequate acclimatisation period (at least 1 week) under laboratory conditions

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

Semiocclusive dressing (gauze dressing) of 6 cm2 loaded with 0.5 g test material.

Duration of treatment / exposure:

The exposure of the test animals was 4h.

Observation period:

The obervation period of the test animals was 21d.

Number of animals:

Three male rabbits were used as test animals.

Details on study design:

The test item was tested for its acute skin irritation on the shaved back skin of three rabbits (Kleinrussen, Chbb:HM). The contact time under semiocclusive conditions amounts to four hours. [Method: Off. J. Europ. Commun. L 251, 27, 106-108 (1984) and OECD-Guidelines for Testing of Chemicals No 404].

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

three animals

Time point:

other: 1 h

Score:

1

Max. score:

1

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

three animals

Time point:

other: 1 h

Score:

3

Max. score:

3

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

three animals

Time point:

24 h

Score:

1.67

Max. score:

2

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

three animals

Time point:

24 h

Score:

3

Max. score:

4

Remarks on result:

positive indication of irritation

Results 5

Irritation parameter:

erythema score

Basis:

mean

Remarks:

three animals

Time point:

48 h

Score:

2.67

Max. score:

3

Remarks on result:

positive indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

three animals

Time point:

48 h

Score:

3

Max. score:

3

Remarks on result:

positive indication of irritation

Results 7

Irritation parameter:

erythema score

Basis:

mean

Remarks:

three animals

Time point:

72 h

Score:

3.67

Max. score:

4

Reversibility:

fully reversible within: 21 d

Remarks on result:

positive indication of irritation

Results 8

Irritation parameter:

edema score

Basis:

mean

Remarks:

three animals

Time point:

72 h

Score:

2.33

Max. score:

3

Reversibility:

not fully reversible within: 21 d

Remarks:

Eschar and scar formation in two of three test animals after 21 d.

Remarks on result:

positive indication of irritation

Results 9

Irritation parameter:

erythema score

Basis:

mean

Remarks:

three animals

Time point:

24/48/72 h

Score:

>= 2

Max. score:

4

Reversibility:

fully reversible within: 21 d

Remarks on result:

positive indication of irritation

Results 10

Irritation parameter:

edema score

Basis:

mean

Remarks:

three animals

Time point:

24/48/72 h

Score:

>= 2

Max. score:

4

Reversibility:

not fully reversible within: 21 d

Remarks on result:

positive indication of irritation

Any other information on results incl. tables

Results

The test item was tested for its acute skin irritation on the shaved back skin of three rabbits (Kleinrussen, Chbb:HM). The contact time under semiocclusive conditions amounts to four hours. [Method: Off. J. Europ. Commun. L 251, 27, 106-108 (1984) and OECD-Guidelines for Testing of Chemicals No 404]. Strong erythema and edema were observed 1-72 hours after the exposition. At two animals scarring was observed at the application side 21 days after the exposure. The substance is classified as corrosive to the skin.

Table1 : Symptoms

Skin reactions	mean value (24/48/72 h)	number of animals
Erythema	>= 2	3
Oedema	>= 2	3

Scar formation was observed in two animals after a 21d observation period.

Table 2: Assessment of skin reactions

Animal No.	Hours after exposure [h]
	1		24		48		72
	Erythema	Oedema	Erythema	Oedema	Erythema	Oedema	Erythema	Oedema
1	1	3 b	2	4 n e	3	3 n e	4	3 n e
2	1	3 b	2	2 n e	3	3 n e	4	2 n e
3	1	3 b	1	3 n e	2	3 n e	3	2 n e

b = brownish discoloration of skin

n = necrosis

e = eschar formation

Table 3: Assessment of skin reactions

Animal No.	Days after exposure [d]
	7	14	21	21
	reversibility	reversibility	reversibility	Erythema	Oedema
1	no	no	no	0	0 s e
2	no	no	no	0	0 s e
3	no	no	yes	0	0

e = eschar foramtion

s = scar formation

Applicant's summary and conclusion

Interpretation of results:

Category 1 (corrosive) based on GHS criteria

Conclusions:

The test item was tested for its acute skin irritation on the shaved back skin of three rabbits in an OECD 404 study. Based on the results of the study the substance is classified as corrosive to the skin.

Executive summary:

The test item was tested for its acute skin irritation on the shaved back skin of three rabbits (Kleinrussen, Chbb:HM). The contact time under semiocclusive conditions amounts to four hours. [Method: Off. J. Europ. Commun. L 251, 27, 106-108 (1984) and OECD-Guidelines for Testing of Chemicals No 404]. Strong erythema and edema were observed 1-72 hours after the exposition. At two animals scarring was observed at the application side 21 days after the exposure. The substance is classified as corrosive to the skin.