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

Endpoint summary

Description of key information

Data obtained for the target substance sulfuric acid, mono-C12-14 (even numbered)-alkyl esters, magnesium salts (CAS 90583-23-6).

Skin irritation / corrosion (OECD 404, rabbit): irritating to skin

Eye irritation (similar OECD 405, rabbit): serious eye damage

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

not stated

Deviations:

no

GLP compliance:

yes

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

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

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

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

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.

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

Interpretation of results:

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

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 August - 14 September 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Only limited information regarding test substance and test animals available and no iris score reported

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

not stated

Deviations:

yes

Remarks:

no iris score is reported

GLP compliance:

no

Species:

rabbit

Strain:

other: Kleinrusse Chbb:HM

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Fa. Thomae, Biberach, Germany
- Age at study initiation: young adult
- Weight at study initiation: 2482.5 g (mean of all 4 animals)

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 10% concentration of test substance in water

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

21 days
Reading time points: 1, 6, 24, 48 and 72 h and 7, 10, 14, 17, and 21 days

Number of animals or in vitro replicates:

4 male

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed/rinsed off after instillation of test substance

SCORING SYSTEM: Draize scoring system

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 4 animals

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 21 days in 2 animals

Remarks:

fully reversible within 7 - 14 days in 2 animals

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of animals #1 and #2

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of animals #3 and #4

Time point:

24/48/72 h

Score:

2.3

Max. score:

3

Reversibility:

not fully reversible within: 21 days in 1 animal

Remarks:

fully reversible within 14 days in 1 animal

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of animals #1 and #2

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 10 days

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Remarks:

Although no data on iritis (iris score) is reported, the available data on eye irritiation / damage is unambiguous and sufficient to derive a reliable classification and labelling.

Irritant / corrosive response data:

Individual corneal, conjunctivae and chemosis scores are summarised in the table in section “Any other information on results incl. tables”. No data are available regarding iritis. The test substance caused a slight corneal reactions in all animals (score 1). While the corneal reactions were fully revesible within 7 - 14 in 2 of the animals, they persisted until the end of the observation period after 21 days in the remaining 2 animals. The test substance also induced conjunctivae reactions. Moderate redness of the conjuntivae (score 2) was observed in 2 of the 4 animals which was fully revesible within 7 days. Redness (mean score 2.3 of 2/4 animals) of the conjunctivae was also visible in the other 2 animals with full reversion of the effect on day 21 of the observation period. Swelling (chemosis) of the conjuctivae was another effect observed after exposure to the test substance. While 2/4 animals exhibited only slight chemosis (max. score 1) that was fully reversible within 72 h after exposure, the effect lasted until day 7 in 1 animal and until day 10 in the remaining animals.

Other effects:

No further local or systemic effects were observed.

Table 1: Results of eye irritation test in rabbits after application of Sulfuric acid, mono-C12-14 (even numbered)-alkyl esters, magnesium salts (10% active substance)

Rabbit No. / sex	Scoring* after	Cornea	Iris	Conjunctiva
				Redness	Chemosis
1	1 h	0	no data	1	1
	24 h	1	no data	2	1
	48 h	1	no data	2	1
	72 h	1	no data	2	0
	7 d	1	no data	0	0
	14 d	0	no data	0	0
	21 d	0	no data	0	0
Individual mean (24, 48, 72 h)		1.0		2.0	0.7
2	1 h	0	no data	1	1
	24 h	1	no data	2	1
	48 h	1	no data	2	1
	72 h	1	no data	2	0
	7 d	0	no data	0	0
	14 d	0	no data	0	0
	21 d	0	no data	0	0
Individual mean (24, 48, 72 h)		1.0		2.0	0.7
3	1 h	0	no data	1	2
	24 h	1	no data	2	1
	48 h	1	no data	3	1
	72 h	1	no data	2	1
	7 d	1	no data	2	0
	14 d	1	no data	2	0
	21 d	1	no data	2	0
Individual mean (24, 48, 72 h)		1.0		2.3	1.0
4	1 h	0	no data	1	2
	24 h	1	no data	2	2
	48 h	1	no data	3	1
	72 h	1	no data	2	1
	7 d	1	no data	2	1
	14 d	1	no data	0^a	0
	21 d	1	no data	0^a	0
Individual mean (24, 48, 72 h)		1.0		2.3	1.3

*Scoring according to Draize scheme

^aconjunctival blood infiltration observed

Interpretation of results:

other: Eye damage 1, H318. Classification according to Regulation (EC) No 1272/2008 (CLP/EU GHS)

Conclusions:

Due to the irreversible nature of the corneal reactions (opacity score 1 after 21 days in 2/4 animals), the test substance has to be classified as eye damage 1, H318, according to Regulation (EC) No 1272/2008 (CLP). Although no data on iritis (iris score) is reported, the available data on eye irritiation / damage is unambiguous and sufficient to derive a reliable classification and labelling.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation / corrosion

There is one relevant study for the target substance sulfuric acid, mono-C12-14 (even numbered)-alkyl esters, magnesium salts (CAS 90583-23-6) addressing skin irritation. The study was conducted according to OECD Guideline 404, observing GLP conditions (BASF, 1987a). The neat test substance was applied to the clipped skin of 5 male Kleinrusse rabbits under occlusive conditions for 4 h. Skin reactions were observed 1, 24, 48 and 72 h and 7, 10, 14, 17 and 21 days after application. 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. The substance, therefore, demonstrated irritating properties.

Eye irritation

In a study performed similar to OECD Guideline 405 the target substance sulfuric acid, mono-C12-14 (even numbered)-alkyl esters, magnesium salts (10% concentration of test substance in water) was applied to the eyes of 4 male Kleinrusse rabbits (BASF, 1987b). The study was not conducted under GLP conditions. The effects of the test substance were observed 1, 6, 24, 48 and 72 h and 7, 10, 14, 17 and 21 days after exposure. No data regarding iritis were detailed in the study report. The test substance caused a slight corneal reactions in all animals (score 1). While the corneal reactions were fully revesible within 7 - 14 in 2 of the animals, they persisted until the end of the observation period after 21 days in the remaining 2 animals. The test substance also induced conjunctivae reactions. Moderate redness of the conjuntivae (score 2) was observed in 2 of the 4 animals which was fully revesible within 7 days. Redness (mean score 2.3 of 2/4 animals) of the conjunctivae was also visible in the other 2 animals with full reversion of the effect on day 21 of the observation period. Swelling (chemosis) of the conjuctivae was another effect observed after exposure to the test substance. While 2/4 animals exhibited only slight chemosis (max. score 1) that was fully reversible within 72 h after exposure, the effect lasted until day 7 in 1 animal and until day 10 in the remaining animals. Although no data on iritis (iris score) was reported, the available data on eye irritiation / damage is unambiguous and sufficient to derive a reliable classification and labelling. Based on the irreversible corneal reactions, the substance is considered to induce serious eye damage.

Justification for classification or non-classification

The available data on skin irritation and eye irritation / serious eye damage obtained with the target substance sulfuric acid, mono-C12-14 (even numbered)-alkyl esters, magnesium salts (CAS 90583-23-6) meet the criteria of the CLP Regulation (EC) No. 1272/2008 for skin irritation and serious eye damage. The substance, therefore, needs to be classified as Skin Irrit. 2, H315, and Eye Damage 1, H318.

Since inhalation of the neat substance in powder form (bulk density < 400 g/L) cannot be excluded, and based on the irritating properties observed for skin and eyes, it is expected that the mucous membranes of the respiratory tract are also subject to irritating effects. In consequence, the target substance in its powder form with a bulk density < 400 g/L is additionally classified as respiratory irritant (STOT SE 1, H335) in a worst case approach.