Reaction products of decanoic acid and lauric acid with glycerol and polyglycerol

Endpoint summary

Description of key information

skin irritation: not irritating (OECD TG 404; RL2, GLP); very slight erythema (grade 1) in 2/3 animals up to 48 h after patch removal, fully reversible within 72 h

eye irritation: not irritating (OECD TG 405; RL2, GLP); 2/3 animals showed ocular secretion after treatment; iris inflammation in 2/3 animals 1 h after application; conjunctival redness and chemosis up to day 2-5 after application

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:

1992-10-06 to 1992-10-09

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

May 12, 1981

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Housing: individual housing (50 x 45 x 40 cm, L x B x H) in a battery of cages, each equipped with a paper roll disposal system
- Diet (e.g. ad libitum): ad libitum, Ssniff K-Haltung (Zuchtdiät für Kaninchen), Form: pellets, 1.0-1.5 cm long, 0.5 cm diameter, Ssniff Spezialdiäten GmbH, 4770 Soest/Westfalen
- Water (e.g. ad libitum): ad libitum, drinking water as for human consumption, System: drinking nipples

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12h light/ 12h dark cycles

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: adjacent area of untreated skin served as negative control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

30-60 min after removal of the semi-occlusive dressing and 24, 48 and 72 h after patch removal

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: ca. 6 cm²
- Type of wrap if used: Ypsiplast ® (Holthaus Medical), held by non-irritating tape Elastoplast ® (Beiersdorf AG, Hamburg) and Stülpa ® (P. Hartmann AG, Heidenheim-Brenz)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual sample was carefully washed off with water or an appropriate solvent
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) Day of exposure at 30-60 min after patch removal and 24, 48 and 72 h after patch removal

SCORING SYSTEM: according to OECD Test Guideline 404

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Very slight erythema (grade 1) was observed in 2/3 animals up to 48 h after patch removal, which were fully reversible within 72 h.

Other effects:

No other effects observed

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

 

Score at time point / Reversibility	Erythema Max. score: 4	Edema Max. score: 4
30 – 60 min	1/0/1	0/0/0
24 h	1/0/1	0/0/0
48 h	1/0/1	0/0/0
72 h	0/0/0	0/0/0
Average 24h, 48h, 72h	0.67/0/0.67	0/0/0

 

Interpretation of results:

GHS criteria not met

Conclusions:

Polyglycerin caprinate was not irritating in thin in vivo skin irritation study in rabbit.

Executive summary:

In a in vivo dermal irritation study according to OECD Test Guideline 404 (1981), three New Zealand White rabbits were dermally exposed to 0.5 mL of Polyglycerin caprinate (> 95% a.i.) for 4 h to 6 cm² skin area.  Animals then were observed for 72 h.  Irritation was scored by the method of OECD Test Guideline 404.

During the observation period only slight erythema (grade 1) in two of the three animals occurred, the observed effects were reversible within 72 h after application. In this study, Polyglycerin caprinate is not a dermal irritant.

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:

experimental study

Adequacy of study:

key study

Study period:

1992-10-08 to 1992-10-14

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

February 24, 1987

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Housing: individual housing (50 x 45 x 40 cm, L x B x H) in a battery of cages, each equipped with a paper roll disposal system
- Diet (e.g. ad libitum): ad libitum, Ssniff K-Haltung (Zuchtdiät für Kaninchen), Form: pellets, 1.0-1.5 cm long, 0.5 cm diameter, Ssniff Spezialdiäten GmbH, 4770 Soest/Westfalen
- Water (e.g. ad libitum): ad libitum, drinking water as for human consumption, System: drinking nipples

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12h light/ 12h dark cycles

Vehicle:

unchanged (no vehicle)

Controls:

other: contralateral untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

the eye were not washed after treatment

Observation period (in vivo):

24, 48 and 72 h after treatment and thereafter once daily up to days 5-6 post application

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed


SCORING SYSTEM: According to OECD Test Guideline 405

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 6 days

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 h

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 5 days

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 6 days

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

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: 4 days

Irritant / corrosive response data:

2/3 animals showed ocular secretion after treatment. Iris inflammation was observed in 2/3 animals 1 h after application of the test item. In all animals, conjunctival redness and chemosis were observed up to day 2-5 after application of the test item.

Other effects:

no other effects observed

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

 

Score at time point / Reversibility	Cornea Max. score: 4	Iris Max. score: 2	Conjunctivae Max. score: 3	Chemosis Max. score: 4
60 min	0/0/0	1/1/0	1/1/2	2/1/1
24 h	0/0/0	0/0/0	2/1/2	2/1/1
48 h	0/0/0	0/0/0	2/1/2	2/1/1
72 h	0/0/0	0/0/0	1/0/1	1/0/1
Average 24h, 48h, 72h	0/0/0	0/0/0	1.67/0.67/1.67	1.67/0.67/1
Reversibility*)	c	c	c	c
4 d	0/0/0	0/0/0	1/0/1	0/0/0
5 d	0/0/0	0/0/0	1/0/0	100/0
6 d	0/#/#	0/#/#	0/#/#	0/#/#

 

# In animals 2 and 3 the test was terminated after examination on day 5

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Interpretation of results:

GHS criteria not met

Conclusions:

In this study, Polyglycerin caprinate was not irritating to the eye.

Executive summary:

In a primary eye irritation study according to OECD guideline 405 (February 24, 1987) 0.1 mL of polyglycerin caprinate (>95% a.i.) was instilled into the conjunctival sac of the left eye of 3 New Zealand White rabbits, the untreated right eye of each animal served as control. The were not rinsed after treatment. The animals were observed for clinical signs of eye irritation and inflammation at 1 h after instillation and after 24, 48 and 72h, thereafter the animals were examined once daily up to day 5 -6. Two animals (no. 1 and 3) showed ocular secretion after treatment. Iris inflammation was observed in animal no. 1 and 2, 1 h p.a. In all animals signs of redness and chemosis of the conjunctivae were observed up to 2-5 days p.a. All detected effects were reversible within 6 days p.a. Thus, the test item is considered to be not irritating to the eye according to GHS criteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

In a in vivo dermal irritation study according to OECD Test Guideline 404 (1981), three New Zealand White rabbits were dermally exposed to 0.5 mL of Polyglycerin caprinate (> 95% a.i.) for 4 h to 6 cm² skin area. Animals then were observed for 72 h. Irritation was scored by the method of OECD Test Guideline 404.

During the observation period only slight erythema (grade 1) in two of the three animals occurred, the observed effects were reversible within 72 h after application. In this study, Polyglycerin caprinate is not a dermal irritant.

 

Eye irritation

In a primary eye irritation study according to OECD guideline 405 (February 24, 1987) 0.1 mL of

polyglycerin caprinate (>95% a.i.) was instilled into the conjunctival sac of the left eye of 3 New Zealand White rabbits, the untreated right eye of each animal served as control. The were not rinsed after treatment. The animals were observed for clinical signs of eye irritation and inflammation at 1 h after instillation and after 24, 48 and 72h, thereafter the animals were examined once daily up to day 5 -6.

Two animals (no. 1 and 3) showed ocular secretion after treatment. Iris inflammation was observed in animal no. 1 and 2, 1 h p.a. In all animals signs of redness and chemosis of the conjunctivae were observed up to 2-5 days p.a. All detected effects were reversible within 6 days p.a. In this study, Polyglycerin caprinate is not irritating to the eye.

 

Respiratory irritation

No data on the respiratory irritation of polyglycerin caprylate/caprinate are available.

There are no data gaps for the endpoint irritation/corrosion. No human information is available for this endpoint. However, there is no reason to believe that these results would not be applicable to humans.

Justification for classification or non-classification

Based on the available data polyglycerin caprylate/caprinate does not need to be classified for skin and eye irritation according to regulation (EC) 1272/2008.