Phosphoric acid, mono- and di-C11-14 (linear and branched) alkyl esters

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to Guideline study, tested with the source substance Phosphoric acid, C9-15 branched and linear alkyl esters, potassium salts.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

not specified

Type of study:

guinea pig maximisation test

Test material

Test material information

Constituent 1

Reference substance name:

97468-13-8 (Phosphoric acid, C9-11-branched and linear alkyl esters, potassium salts ) and 91844-80-3 (Phosphoric acid, C13-15-branched and linear alkyl esters, potassium salts); 50/50; 25% solution (solvent purification)

IUPAC Name:

97468-13-8 (Phosphoric acid, C9-11-branched and linear alkyl esters, potassium salts ) and 91844-80-3 (Phosphoric acid, C13-15-branched and linear alkyl esters, potassium salts); 50/50; 25% solution (solvent purification)

Constituent 2

Reference substance name:

Phosphoric acid, C9-15 branched and linear alkyl esters, potassium salts (25%) solution (solvent purification)

IUPAC Name:

Phosphoric acid, C9-15 branched and linear alkyl esters, potassium salts (25%) solution (solvent purification)

Test material form:

other: liquid

Details on test material:

- Test material: potassium salt of alkyl (C=9-15) phosphate (25%) solution (solvent purification)

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Japan SLC, Inc.
- Weight at study initiation: ca.350g
- Housing: 4-5 amimals / metalic cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23+/-2
- Humidity (%): 50+/-10
- Air changes (per hr): 17 times/hr
- Photoperiod (hrs dark / hrs light): 12 hr/12 hr

IN-LIFE DATES: From: 1992-02-04 to 1992-03-08

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

water

Induction 2

Concentration / amount:

Induction:
interdermal with act.0.1 % test solution
dermal with act 5 % test solution

Challenge concentration:
act. 1.0 % and 0.5 % test solution

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

water

Challenge 2

Concentration / amount:

Induction:
interdermal with act.0.1 % test solution
dermal with act 5 % test solution

Challenge concentration:
act. 1.0 % and 0.5 % test solution

No. of animals per dose:

4 females for intradermal treatment in preliminary study.
4 females for epicutaneous (occlusive) treatment in preliminary study.
10 females for treatment group in main study.
5 females for control group in main study.

Details on study design:

PRELIMINARY STUDY
A. Topical application
Irritation assessment following 24h occlusive exposure to test material at act. 10, 5, 1, 0.5, 0.1 and 0.05% in water; skin assessment 3, 24 and 48 hr after treatment.
Result: act. 5% will be used for induction phase and act. 1.0 and 0.5 % will be used for challenge in main study.

B. Intradermal
0.1 ml of test substance at act. 1.0, 0.5, 0.1, 0.05 % solution applied intradermally in physiological saline. Assessments was made 24, 48 and 72h post‐administration.
Result: act. 0.1 % will be used in main study.

MAIN STUDY
A. INDUCTION EXPOSURE
Day 0: Treatment group:
− Injection 1: 1:1 mixture (v/v) FCA/physiological saline
− Injection 2: 0.1 % test substance in physiological saline
− Injection 3: 0.1 % test substance in a 1:1 mixture (v/v) FCA/physiological saline
Control group:
- Injection 1: 1:1 mixture (v/v) FCA/physiological saline
- Injection 2: physiological saline
- Injection 3: 1:1 mixture (v/v) FCA/physiological saline

Day 7: Treatment group:
Region, free of fur, was treated topically with a 2 x 4 cm patch of Lint cloth, fully loaded with an 0.2 mL of test substance solution (act. 5%). Patch was covered by an occlusice bandage and left in place for 48 hours.
Control group:
Only vehicle (distilled water) was applied.


B. CHALLENGE EXPOSURE
Day 21: Flank of all animals, including controls, treated topically with 0.1 ml of act. 1.0 and 0.5 % solution in distilled water of test substance for 24h under an occlusive patch.

GRADING SYSTEM
Dermal reactions graded by the following criteria:

-; 0; no reaction
+-; 1; a slight erythema
+; 2; clear erythema
++; 3; clear erythema with edema
+++; 4; eschar, necrosis

Challenge controls:

In challenge phase, 91 -S-008 [Diadol 115L-MAP K (25%) solution (liquid–liquid extraction)] and 91 -S-007 -B
[Diadol 115L-MAP K (25%) solution (no purification)] were also used in the same concentrations.

Positive control substance(s):

no

Results and discussion

Any other information on results incl. tables

 

Table  Skin sensitization study of diadol115L-MAP K (25%) solution (solvent purification) in guinea pigs (GPMT method)

Test substance		Concentration (%)	Vehicle	Test group			Control
				Average reaction intensity			Average reaction intensity
				Max	Positive (+)	Time	Max	Positive (+)	Time
1	91-S-007-A	1.0	water	0	0	-	0	0	-
2	91-S-007-A	0.5	water	0	0	-	0	0	-
3	91-S-008	1.0	water	0	0	-	0	0	-
4	91-S-008	0.5	water	0	0	-	0	0	-
5	91-S-007-B	1.0	water	0	0	-	0	0	-
6	91-S-007-B	0.5	water	0	0	-	0	0	-

 

Table  Intradermal injection of 91-S-007-A [diadol 115L-MAP K (25%) solution (solvent purification)]

Observation		24 hr				48 hr				72 hr
concentration		1 %	0.5 %	0.1 %	0.05 %	1 %	0.5 %	0.1 %	0.05 %	1 %	0.5 %	0.1 %	0.05 %
No. of animals		4	4	4	4	4	4	4	4	4	4	4	4
judge	-	0	0	0	2	0	0	0	3	0	0	0	4
	+-	0	0	1	2	0	0	2	1	0	0	3	0
	+	0	0	3	0	0	0	2	0	0	0	1	0
	++	0	0	0	0	0	0	0	0	0	0	0	0
	+++	4	4	0	0	4	4	0	0	4	4	0	0

vehicle: physiological saline

 

 

Table  24 hours occlusive patch of 91-S-007-A [diadol 115L-MAP K (25%) solution (solvent purification)]

Observation		3 hr after patch removal						24 hr after patch removal						48 hr after patch removal
concentration		a	b	c	d	e	f	a	b	c	d	e	f	a	b	c	d	e	f
No. of animals		4	4	4	4	4	4	4	4	4	4	4	4	4	4	4	4	4	4
judge	-	0	0	4	4	4	4	0	0	4	4	4	4	0	0	4	4	4	4
	+-	0	1	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0
	+	0	3	0	0	0	0	0	3	0	0	0	0	0	3	0	0	0	0
	++	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	+++	4	0	0	0	0	0	4	0	0	0	0	0	4	0	0	0	0	0

vehicle: physiological saline

concentration a: 10%, b: 5%, c: 1%, d: 0.5%, e: 0.1%, f: 0.05%

 

Table  24 hours occlusive patch of 91-S-008 [diadol115L-MAP K (25%) solution (liquid-liquid extraction)]

Observation		3 hr after patch removal						24 hr after patch removal						48 hr after patch removal
concentration		a	b	c	d	e	f	a	b	c	d	e	f	a	b	c	d	e	f
No. of animals		4	4	4	4	4	4	4	4	4	4	4	4	4	4	4	4	4	4
judge	-	0	0	4	4	4	4	0	0	4	4	4	4	0	0	4	4	4	4
	+-	0	1	0	0	0	0	0	2	0	0	0	0	0	2	0	0	0	0
	+	0	3	0	0	0	0	0	2	0	0	0	0	0	2	0	0	0	0
	++	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	+++	3	0	0	0	0	0	4	0	0	0	0	0	4	0	0	0	0	0

vehicle: physiological saline

concentration a: 10%, b: 5%, c: 1%, d: 0.5%, e: 0.1%, f: 0.05%

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)

Conclusions:

The test substance can be classified as a non-sensitiser to the guinea pig under the conditions of this study.

Executive summary:

Skin sensitization potential of Phosphoric acid, C9-15 branched and linear alkyl esters, potassium salts (25%) solution (solvent purification) was studied in female guinea pigs by the Maxmization test. The animals were induced by intradermal injection and topical application of the test article in the clipped shoulder region.

No erythema nor edema was observed in the test article or vehicle control group by challenging with 1.0 and 0.5 % solution of the test article.

From the results, Phosphoric acid, C9-15 branched and linear alkyl esters, potassium salts was concluded to have no skin sensitization potential in the conditions used in this study.