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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

The read across for substance, CAS: 70851-04-6; EC: 453-480-2; is based upon the analogous substances to which basic form, degree of substitution  of functional groups is not considered to effect the proposed read across for the endpoint of skin irritation/corrosion. Based on the information available for the read across substances, the substance is expected to be irritating or corrosive to skin.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Composition of test substance unclear.
Principles of method if other than guideline:
Application of 0.5 mL to an area of approx. 2.5 cm x 2.5 cm.
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
- Weight at study initiation: 3.3 - 4.0 kg
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): pure compound (containing up to 2% of an additive package which was not further specified by the sponsor)
Duration of treatment / exposure:
4 h
Observation period:
12 d
Reading time points: 30 - 60 min, 24, 48, 72, 96 h, 7, 8 and 12 d
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm² on the shorn left flank (dorso-lumbar region)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water upon the removal of the dressing
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system
Irritation parameter:
erythema score
Basis:
animal: #15
Time point:
other: mean over 24 h, 48 h and 72 h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 12 d
Irritation parameter:
erythema score
Basis:
animal: #16
Time point:
other: mean over 24 h, 48 h and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
erythema score
Basis:
animal: #17
Time point:
other: mean over 24 h, 48 h and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
edema score
Basis:
animal: #15
Time point:
other: mean over 24 h, 48 h and 72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 4 d
Irritation parameter:
edema score
Basis:
animal: #16
Time point:
other: mean over 24 h, 48 h and 72 h
Score:
3.7
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
edema score
Basis:
animal: #17
Time point:
other: mean over 24 h, 48 h and 72 h
Score:
3.7
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritant / corrosive response data:
Following the single 4-hour application, moderate to severe erythema and moderate to severe edema were observed for 2 or 3 days after application in all animals. This regressed and no signs of erythema or edema were evident 4 to 12 days after application. Thickening of the skin at the application site was seen on one animal between 4 and 7 days after application. No other signs of irritations were observed.
Other effects:
Yellow staining by the test sample was observed at the application site of one animal one day after application but this did not obscure the assessment of any erythema that was present.

Table 1: Erythema score

Animal Number

1 h

24 h

48 h

72 h

4 days

7 days

8 days

12 days

Mean Score (24 -72 h)  

15

4

3

3

2

2

 1

0

 1.0

16

3

3

2

1

1

 0

 1.3

17

4

3

2

1

1

 

 0

 1.3

 

Table 2: Edema Score

Animal Number

1 h

24 h

48 h

72 h

4 days

7 days

8 days

12 days

Mean Score (24 -72 h)

15

4

3

4

2

0

0

-

0

3.0

16

4

4

4

3

3

-

 0

-

3.7

17

4

4

4

3

3

 -

 0

-

3.7
Interpretation of results:
other: inconclusive
Remarks:
Criteria used for interpretation of results: EU
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Composition of test substance unclear.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Lack of details in study documentation
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3.5 - 3.8 g
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
12 d
Reading time points: 30 - 60 min, 24, 48, 72 h, 7, 11 and 12 d
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm² on the shorn left flank (dorso-lumbar region)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water upon the removal of the dressing
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system
Irritation parameter:
erythema score
Basis:
animal: #15
Time point:
other: mean over 24 h, 48 h and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 12 d
Irritation parameter:
erythema score
Basis:
animal: #16
Time point:
other: mean over 24 h, 48 h and 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 11 d
Irritation parameter:
erythema score
Basis:
animal: #17
Time point:
other: mean over 24 h, 48 h and 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
edema score
Basis:
animal: #15
Time point:
other: mean over 24 h, 48 h and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
edema score
Basis:
animal: #16
Time point:
other: mean over 24 h, 48 h and 72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
edema score
Basis:
animal: #17
Time point:
other: mean over 24 h, 48 h and 72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritant / corrosive response data:
Following the single 4-hour application, very slight to well-defined erythema and very slight to slight oedema were observed in all animals. This regressed and no signs of erythema or oedema were evident 11 or 12 days after application. Slight desquamation at the application site of one animal was observed 7 days after application.

Table 1: Erythema score

Animal Number

1 h

24 h

48 h

72 h

7 days

11 days

12 days

Mean Score (24 -72 h)

15

2

-

1

1

1

 -

0

1.0

16

2

2

1

1

1

0

 -

1.3

17

1

2

1

1

0

 -

 -

1.3

 

Table 2:Edema Score

Animal Number

1 h

24 h

48 h

72 h

7 days

11 days

12 days

Mean Score (24 - 72 h)

15

1

-

1

1

0

 -

0

1.0

16

2

2

2

1

0

0

1.7

17

1

2

2

1

0

 -

 -

1.7

Interpretation of results:
other: inconclusive
Remarks:
Criteria used for interpretation of results: EU
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. (Limited documentation but relevant data given)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
limited documentation but relevant data given
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 5.0 - 5.2 g
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
4 d
Reading time points: 30 - 60 min, 24, 48, 72 and 96 h
Number of animals:
3 (females)
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): cleansing with clean warm water
- Time after start of exposure: 4 h (upon removal of the dressing)

SCORING SYSTEM: Draize scoring system
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 4 d
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 4 d
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 4 d
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h

Table 1: Erythema scores

Animal Number

24 hours

48 hours

72 hours

96 hours

Mean Score

26

2

1

1

0

1.3

35

2

2

1

0

1.7

36

2

1

1

0

1.3

 

Table 2: Edema Score

Animal Number

24 hours

48 hours

72 hours

96 hours

Mean Score

26

1

0

0

0

0.3

35

1

0

0

0

0.3

36

1

0

0

0

0.3

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Remarks:
1 substance available for read-across
Adequacy of study:
other information
Justification for type of information:
see the attached justification in Section 13 for full details.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
erythema score
Basis:
animal: #15
Time point:
other: mean over 24 h, 48 h and 72 h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 12 d
Remarks on result:
other: CAS 68424-31-7 (1991b)
Irritation parameter:
erythema score
Basis:
animal: #16
Time point:
other: mean over 24 h, 48 h and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: CAS 68424-31-7 (1991b)
Irritation parameter:
erythema score
Basis:
animal: #17
Time point:
other: mean over 24 h, 48 h and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: CAS 68424-31-7 (1991b)
Irritation parameter:
edema score
Basis:
animal: #15
Time point:
other: mean over 24 h, 48 h and 72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 4 d
Remarks on result:
other: CAS 68424-31-7 (1991b)
Irritation parameter:
edema score
Basis:
animal: #16
Time point:
other: mean over 24 h, 48 h and 72 h
Score:
3.7
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: CAS 68424-31-7 (1991b)
Irritation parameter:
edema score
Basis:
animal: #17
Time point:
other: mean over 24 h, 48 h and 72 h
Score:
3.7
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: CAS 68424-31-7 (1991b)
Irritation parameter:
erythema score
Basis:
animal: 15
Time point:
other: mean over 24 h, 48 h and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 12 d
Remarks on result:
other: CAS 68424-31-7 (1991c)
Irritation parameter:
erythema score
Basis:
animal: 16
Time point:
other: mean over 24 h, 48 h and 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 11 d
Remarks on result:
other: CAS 68424-31-7 (1991c)
Irritation parameter:
erythema score
Basis:
animal: 17
Time point:
other: mean over 24 h, 48 h and 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: CAS 68424-31-7 (1991c)
Irritation parameter:
edema score
Basis:
animal: 15
Time point:
other: mean over 24 h, 48 h and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: CAS 68424-31-7 (1991c)
Irritation parameter:
edema score
Basis:
animal: 16
Time point:
other: mean over 24 h, 48 h and 72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: CAS 68242-31-7 (1991c)
Irritation parameter:
edema score
Basis:
animal: 17
Time point:
other: mean over 24 h, 48 h and 72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 7d
Remarks on result:
other: CAS 68424-31-7 (1991c)
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 4d
Remarks on result:
other: CAS 68424-31-7 (1991a)
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 4d
Remarks on result:
other: CAS 68424-31-7 (1991a)
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 4d
Remarks on result:
other: CAS 68424-31-7 (1991a)
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48h
Remarks on result:
other: CAS 68424-31-7 (1991a)
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48h
Remarks on result:
other: CAS 68424-31-7 (1991a)
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48h
Remarks on result:
other: CAS 68424-31-7 (1991a)
Interpretation of results:
GHS criteria not met
Conclusions:
The read across for substance, CAS: 70851-04-6; EC: 453-480-2; is based upon the analogous substances to which basic form, degree of substitution of functional groups is not considered to effect the proposed read across for the endpoint of skin irritation/corrosion. Based on the information available for the read across substances, the substance is expected to be irritating or corrosive to skin.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Remarks:
1 substance available for read-across
Adequacy of study:
weight of evidence
Justification for type of information:
see justification attached in Section 13 for full details
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all three animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
other: CAS 68424-31-7
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all three animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable
Remarks on result:
other: CAS 68424-31-7
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all three animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not applicable
Remarks on result:
other: CAS 68424-31-7
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all three animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
other: CAS 68424-31-7
Interpretation of results:
GHS criteria not met
Conclusions:
The read across for substance, CAS: 70851-04-6; EC: 453-480-2; is based upon the analogous substances to which basic form, degree of substitution of functional groups is not considered to effect the proposed read across for the endpoint of eye irritation. Based on the information available for the read across substances, the substance is expected to be not irritating to eyes.
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions (lack of data on test substance and animal husbandry).
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(lack of details on test substance and animal husbandry)
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3.6 - 4.6 kg
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
3 d
Number of animals or in vitro replicates:
3 females
Details on study design:
SCORING SYSTEM: Draize scoring system
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all three animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all three animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all three animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all three animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritant / corrosive response data:
No corneal or iridial effects were observed. Conjunctival effects included slight redness (1 animal) and slight discharge (1 animal) and were transiently seen approx. 1 h after dosing.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation

CAS 68424-31-7

Three primary skin irritation studies were conducted to assess the skin irritation potential of Fatty acids, C5-10, esters with pentaerythritol (CAS 68424-31-7).

In the first primary skin irritation study, which was performed according to OECD Guideline 404 (Robinson, 1991a), the shaved skin of three female New Zealand White rabbits was exposed to 0.5 mL unchanged test substance for 4 hours under semiocclusive conditions. Skin reactions were assessed 1, 24, 48, 72 and 96 hours after removal of the test substance. The exposure period of 4 hours caused slight edema (grade = 1) in all animals 24 hours after removal of the test substance. The effect fully reversed within 48 hours. Erythema was seen at the test site of one animal (grade 2) and slightly at the test site of the other two animals (grade =1). Erythema reactions were completely reversed within 96 hours after removal of the test substance in all three animals. The mean erythema score over 24, 48 and 72 hours was 1.3 for animal #1 and #3 and 1.7 for animal #2. The mean edema score over 24, 48 and 72 hours was 0.3 for all three animals. All treated skin sites appeared normal at the 96 hour observation.

Two further studies, which were performed comparable to OECD Guideline 404, investigated primary dermal irritation of 0.5 mL test substance on the shaved skin of three male New Zealand White rabbits each for a single 4-hour application period (Robinson, 1991b + c). Skin reactions were assessed 1, 24, 48, 72, 96 hours and 7, 8 and 12 days after removal of the test substance. In the first study, moderate to severe erythema (maximum score = 4) and moderate to severe edema (maximum score = 4) were observed for 2 or 3 days after application in all animals. This regressed and no signs of erythema or edema were evident 4 to 12 days after application. Thickening of the skin at the application site was seen on one animal between 4 and 7 days after application. No other signs of irritations were observed. In the second study, very slight to well-defined erythema and very slight to slight oedema were observed in all animals The mean erythema score over 24, 48 and 72 hours was 1 for the first animal and 1.3 for the remaining two animals. The edema score over 24, 48 and 72 hours was 1 for the first animal and 1.7 for the remaining two animals. These reversed and no signs of erythema or oedema were evident 11 or 12 days after application. Slight desquamation at the application site of one animal was observed 7 days after application.

The test material is not considered irritating to the skin in with regard to the studies performed with Tetra-esterification products of C5, C7, C8, C10 fatty acids with pentraerythritol.

Eye Irritation

CAS 68424-31-7

Fatty acids, C5-10, esters with pentaerythritol (CAS 68424-31-7) was tested for its acute eye irritation potential in a study performed comparable to OECD Guideline 405 (Robinson, 1991d). The undiluted test material (0.1 mL) was applied into the conjunctival sac of three female New Zealand White rabbits each. The animals were observed for three days and reactions were assessed 1, 24, 48 and 72 hours after instillation according to the Draize scoring system. No corneal or iridial effects were observed. Conjunctival effects included slight redness (1 animal) and slight discharge (1 animal) and were transiently seen approximately 1 hour after dosing. Thus, the test material is not considered irritating to the eyes in this study.

Justification for classification or non-classification

All available data on skin and eye irritation/corrosion do not meet the classification criteria according to Regulation (EC) 1272/2008.