L-Glutamic acid, N-[4-(4-oxobutyl)benzoyl]-, 1,5-diethyl ester

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 April 2011 to 14 April 2011

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Deviation to good laboratory practices - the study director was not supplied with sufficient test article characterization information.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

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:

1,5-diethyl (2S)-2-{[4-(4-oxobutyl)phenyl]formamido}pentanedioate

EC Number:

700-603-5

Cas Number:

908145-87-9

Molecular formula:

C20 H27 N O6

IUPAC Name:

1,5-diethyl (2S)-2-{[4-(4-oxobutyl)phenyl]formamido}pentanedioate

Details on test material:

Pure active sample of Compound 2945989 was used to perform the testing.
Lot Number: 1050L027
Potency: Assume 100%

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

The animals were housed in individual cages. Absorbent paper bedding was placed beneath the cages and changed at least three times/week. Fresh PMI Rabbit Chow (Diet #5321) was provided daily. Water was available ad libitum. The animal room, reserved exclusively for rabbits on acute tests, was temperature controlled, had a 12 hour light/dark cycle, and was kept clean and vermin free.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: corn oil

Controls:

no

Amount / concentration applied:

The test article was individually weighed, 0.5 g/site and moistened with 1.0 ml of corn oil to form a pasty consistency. The test article was applied under a 2 x 3 cm gauze patch.

Duration of treatment / exposure:

The test article was kept in contact with the skin for 4 hours at which time the wrappings and patches were removed.
Residual test article was removed from the test site by gently washing with corn oil at the end of the exposure period, prior to scoring for dermal reactions

Observation period:

The test sites were observed for dermal irritation at 1, 24, 48 and 72 hours following patch removal.

Number of animals:

Three healthy New Zealand White rabbits (2 males - 1 female)

Details on study design:

The test sites were scored for dermal irritation at 1, 24, 48 and 72 hours following patch removal. Animals were observed for toxicological and pharmacological effects at each dermal observation period and observed for mortality daily. Erythema and edema were scored according to the numerical Draize technique. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction.

Body weights of all animals were recorded pretest and at study termination. All animals were humanely sacrificed using CO2 following study termination.

Results and discussion

In vivo

Results

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 1 hour

Score:

ca. 1

Reversibility:

fully reversible

Irritant / corrosive response data:

Dermal Observations:
Very slight erythema was observed for one animal at 1 hour following 4 hour exposure. There was no other erythema or edema noted at any observation period.

Other effects:

Systemic Observations:
There was no abnormal physical signs noted during the observation period.
All body weight changes were normal.

Any other information on results incl. tables

		Rabbit 1	Rabbit 2	Rabbit 3
1 Hour	Erythema	0	0	1
	Edema	0	0	0
	Systemic Sign	A	A	A
24 Hour	Erythema	0	0	0
	Edema	0	0	0
	Systemic Sign	A	A	A
48 Hour	Erythema	0	0	0
	Edema	0	0	0
	Systemic Sign	A	A	A
72 Hour	Erythema	0	0	0
	Edema	0	0	0
	Systemic Sign	A	A	A

A = normal

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Compound 2945989, Lot/Batch# 1050 L 027 is not a dermal irritant.

Executive summary:

In April 2011 a dermal irritation/corrosion study was conducted as per OECD Guideline 404. Three rabbits were dosed dermally with Intermediate 2945989.  0.5g of the test article was applied dermally to one intact site per rabbit and wrapped with a semi-occlusive dressing. The test article was kept in contact with the skin for 4 hours at which time the wrappings were removed. 

Erythema and edema were scored at 1,24, 48 and 72 hours following patch removal. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction at these time periods. Animals were observed for toxicological and pharmacological effects at each dermal observation period and observed for mortality daily. Body weights were recorded pretest and at termination.

 

Summary:  

Very slight erythema was observed for one animal at 1 hour following the 4 hour exposure. There was no other erythema or edema noted at any observation period. There were no abnormal physical signs noted during the observation period. All body weight changes were normal.

 

Conclusion: 

Compound 2945989, Lot/Batch# 1050 L027 is not a dermal irritant.