Sulfuric acid, mono-C12-14-alkyl esters, magnesium salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03 April - 25 May 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

not stated

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sulfuric acid, mono-C12-14-alkyl esters, magnesium salts

EC Number:

292-222-1

EC Name:

Sulfuric acid, mono-C12-14-alkyl esters, magnesium salts

Cas Number:

90583-23-6

Molecular formula:

Not applicable, UVCB substance

IUPAC Name:

Sulfuric acid, mono-C12-14 (even numbered)-alkyl esters, magnesium salts

Test animals

Species:

rabbit

Strain:

other: Kleinrusse Chbb:HM

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Fa. Thomae, Biberach, Germany
- Age at study initiation: young adult
- Weight at study initiation: 2460 g (mean of all 5 animals)
- Housing: individual cages, Fa. Heinkel, Kuchen, Germany
- Diet: ad libitum (Zucht-/Haltungsdiät 20 ZH 5, Fa. Nohrlin GmbH, Bad Salzuflen, Germany)
- Water: tap water, ad libitum
- Acclimation period: min. 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 45 - 50
- Air changes (per hr): not indicated
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL
- Concentration: undiluted

Duration of treatment / exposure:

4 h

Observation period:

21 days
Reading time points: 1, 24, 48 and 72 h and 7, 10, 14, 17, and 21 days

Number of animals:

5 males

Details on study design:

TEST SITE
- Area of exposure: undiluted test substance was applied to a 2.5 cm x 2.5 cm linen patch
- Type of wrap if used: the patch was fixed to the clipped skin by means of a plastics foil (not further specified) and secured occlusively with adhesive Acrylastics tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed/rinsed off
- Time after start of exposure: 4 h

SCORING SYSTEM:
- Method of calculation: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of all 5 animals

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 2

Irritation parameter:

edema score

Basis:

other: mean of 4 animals (except animal #3)

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 3

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3.3

Max. score:

4

Reversibility:

fully reversible within: 21 days

Irritant / corrosive response data:

Individual erythema and edema scores are summarised in the table in section “Any other information on results incl. tables”. 1 h after removal of the patch moderate to severe erythema (scores 3 and 4) and edema (scores of 2 and 3) were observed in all animals. Erythema (score 2 in 1/5 animals, score 3 in 2/5 animals and score 4 in 2/5 animals) and edema (score 2 in 3/5 animals, score 3 in 1/5 animals and score 4 in 1/5 animals) were still visible at the reading 10 days after exposure to the test substance. At day 14 of the observation period, erythema and edema started to reverse: erythema score 1 in 3/5 and score 2 in the other 2 animals at day 14 and score 0 in 3/5 animals and score 2 in 2/3 animals on day 17; edema score 1 in 4/5 animals and score 0 in the remaining animals on day 14. At the last observation on day 21, all erythema and edema were fully reversed in all animals.

In addition to erythema and edema formation, a brownish discoloration developed in 5/5 animals 24 h after exposure. The discoloration was still detectable in 2/5 animals after 10 days, whereas after 14 days it was also completely reversed in the remaining 2 animals. 7 days after exposure to the test substance eschar formation was observed in all 5 animals. Eschars remained visible in 4/5 animals until day 17 of the obseration period. 1/5 animals exhibited eschars until the end of the test on day 21 while the other 4 animals were free of eschars at that observation point.

Other effects:

No further local or systemic effects were observed.

Any other information on results incl. tables

Table 1: Individual skin examination scores after 4h-exposure to Texapon MGS (Scoring according to Draize scheme)

 

Skin effect	Erythema								Edema
Scoring^a	1 h	24h	48h	72h	7 d	14d	21 d	Mean^b	1 h	24h	48h	72h	7 d	14d	21 d	Mean^b
Animal No. /sex #1	4	4	4	4	4	1	0	4.0	2	4	4	4	4	1	0	4.0
#2	3	4	4	4	4	1	0	4.0	2	4	4	4	3	0	0	4.0
#3	3	4	4	4	4	1	0	4.0	1	3	3	4	4	1	0	3.3
#4	3	4	4	4	4	2	0	4.0	2	4	4	4	3	1	0	4.0
#5	2	4	4	4	4	2	0	4.0	2	4	4	4	4	1	0	4.0

^aTimepoint of reading after substance removal subsequent to 4h-dermal exposure

^bMean of 24, 48 and 72 h scores

Applicant's summary and conclusion

Interpretation of results:

other: Skin irrit. 2, H315. Classification according to Regulation (EC) No 1272/2008 (CLP/EU GHS)