Lauric acid, monoester with propane-1,2-diol

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Study period:

20-27 June 1995

Reliability:

1 (reliable without restriction)

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
[Please provide information for all of the points below. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
A read-across approach has been suggested based on the metabolism of the common structure of propylene glycol fatty acid esters. Read-across is implemented from already existing data from testing on Dapro FX511, on metabolism products (fatty acid and propylene glycol) and on propylene glycol monolaurate.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)

Source chemical:

Dapro FX511
EC Number: 285-503-5
CAS Number: 85114-00-7

Target chemical:

RM1004755: not classified
Einecs No. 248-315-4
CAS No. 27194-74-7

See read-across justification report in section 13

3. ANALOGUE APPROACH JUSTIFICATION
A matrix of data has been created using the Dapro FX511 REACH dossier, read-across document for aquatic tox from Dapro FX510 (source) to Dapro FX511 (target), a HPV test plan for the glycol esters of the aliphatic esters chemicals (including Propylene glycol, monostearate (CAS 1323-39-3)) and a Petition to include propylene glycol monolaurate into 7 CFR 205 (constituent of RM1004755).
See read-across justification report in section 13

4. DATA MATRIX
Data matrix is given in read-across justification report in section 13

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

- Name of test material (as cited in study report): SER-AD FX 511
- Physical state: liquid (colourless, slightly viscous)
- Analytical purity: no data; the purity of the test material was the responsibility of the sponsor
- Storage condition of test material: room temperature

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 w
- Weight at study initiation: 2.62 to 2.73 kg
- Housing: individually in suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 47-68
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

4h

Observation period:

7 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100%
- Type of wrap if used: elasticated corset (TUBIGRIP) wrapped around the trunk

REMOVAL OF TEST SUBSTANCE: yes, by gentle sawbbing with cotton wool soaked in 74% Industrial Methylated Spirits
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize J.H. (1977)

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

Very slight erythema was observed in most animals, 1, 24, 48 and 72 h post-treatment. Very slight edema was noted in two animals 24 h after exposure of the substance on the skin, which only in 1 animals for 72 h. Desquamation was seen in one animal at 48 h, and in 2 at 72 h. All skin reactions disappeared within the 7 day observation period.

Other effects:

No other effects were noted

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is not a skin irritant.

Executive summary:

In this dermal irritation study, 3 young adult New Zealand rabbits, 2 males and 1 female, were exposedviathe dermal route to 0.5 ml of SER-AD FX 511 per animal. The test material was applied as a aliquid for 4 hours to a 2.5x 2.5cm of the body surface area of test animals. Animals then were observed for 7 days. Irritation was scored using the Draize scheme. Very slight erythema was observed in most animals, 1, 24, 48 and 72 h post-treatment. Very slight edema was noted in two animals 24 h after exposure of the substance on the skin, which only in 1 animals for 72 h. Desquamation was seen in one animal at 48 h, and in 2 at 72 h. All skin reactions disappeared within the 7 day observation period. In this study, SER-AD FX 511 was not a dermal irritant. On the basis of this study, SER-AD FX 511 does not warrant classification as being irritating to the skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Study period:

26-30 June 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
[Please provide information for all of the points below. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
A read-across approach has been suggested based on the metabolism of the common structure of propylene glycol fatty acid esters. Read-across is implemented from already existing data from testing on Dapro FX511, on metabolism products (fatty acid and propylene glycol) and on propylene glycol monolaurate.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)

Source chemical:

Dapro FX 511
EC Number: 285-503-5
CAS Number: 85114-00-7

Target chemical:

FM1004755: not classified
Einecs No. 248-315-4
CAS No. 27194-74-7

See read-across justification report in section 13

3. ANALOGUE APPROACH JUSTIFICATION
A matrix of data has been created using the Dapro FX511 REACH dossier, read-across document for aquatic tox from Dapro FX510 (source) to Dapro FX511 (target), a HPV test plan for the glycol esters of the aliphatic esters chemicals (including Propylene glycol, monostearate (CAS 1323-39-3)) and a Petition to include propylene glycol monolaurate into 7 CFR 205 (constituent of RM1004755).
See read-across justification report in section 13

4. DATA MATRIX
Data matrix is given in read-across justification report in section 13

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

- Name of test material (as cited in study report): SER-AD FX 511
- Physical state: liquid (very pale yellow)
- Analytical purity: no data; the purity of the test material was the responsibility of the sponsor
- Storage condition of test material: room temperature

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 w
- Weight at study initiation: 2.88 to 3.10 kg
- Housing: individually in suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 45-64
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
VEHICLE no vehicle used

Duration of treatment / exposure:

1 hour

Observation period (in vivo):

3 days

Number of animals or in vitro replicates:

3 (2 males and 1 female)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not performed, but it is not considered necessary
The eyes of the animals were examined 1, 24, 48, and 72 h after the test substance application. The light source from a standard ophthalmoscope was used.

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: The light source from a standard ophthalmoscope was used to enable the assessment.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.2

Max. score:

1

Reversibility:

not specified

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

not specified

Irritant / corrosive response data:

No corneal effects were detected. The iris appeared inflammed in one animal at 1 h post-treatment, but it was fully reversible within 24 h. Minimal irritation of the conjuctivae was seen in two animals at 24 h.

Interpretation of results:

other: slightly irritating

Conclusions:

The substance is not an eye irritant.

Executive summary:

In this eye irritation study, 0.5 ml of SER-AD FX 511 was instilled into the conjunctival sac of the right eye of 3 young adult New Zealand White rabbits (1 female and 2 males). Animals were then observed for the following 72 h. Irritation was scored using the Draize scheme for unwashed eyes at time point of 24, 48 and 72 h post-treatment. No corneal effects were detected. The iris appeared inflammed in one animal at 1 h post-treatment, but it was fully reversible within 24 h. Minimal irritation of the conjuctivae was seen in two animals at 24 h. SER-AD FX 511 induced slight irritation that was reversed during the study period. On the basis of this study, SER-AD FX 511 does not warrant classification as being an eye irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Neither the skin irritation or the eye irritation studies were classified as irritating therefore RM1004755 is considered to be non-irritating and does not require classification